The Africa non-communicable diseases (NCD) Open Lab: Impact of a portfolio of clinical studies to deepen the understanding of NCDs in sub-Saharan Africa.

Background: Clinical research in sub-Saharan Africa (SSA) has often focussed on communicable diseases. However, with the increasing burden of non-communicable diseases (NCDs), there is a need for Africa-specific NCD research. Methods: GSK established the Africa NCD Open Lab in 2014. Three calls for proposals were advertised through various media channels. An external independent scientific advisory board, predominantly representing African scientists and NCD experts, reviewed and selected projects to receive funding. An additional programme in the Africa NCD Open Lab was designed to build statistical capability by supporting training initiatives. We assessed the impact of the Africa NCD Open Lab in three ways: scientific quality with impact; research training and professional development; and research environments. We captured metrics through regular reports/interactions with researchers; via a final report; and through exit interviews with principal investigators. Results: Twenty projects in 11 African countries were funded; reports from 18 completed projects are available (data capture is ongoing). Overall, 139 articles have been published in peer-reviewed journals and other data have been presented at conferences and other forums. Most completed projects led to positive outcomes, such as further research, informing policy, or positively impacting clinical care, including three projects that saw changes to regional or national practice guidelines: the CREOLE study in Nigeria; the African Severe Asthma Program in Uganda; and the African Prospective Study on the Early Detection and Identification of Cardiovascular Disease and Hypertension in South Africa. Participation in the Africa NCD Open Lab led to the award of 34 grants related to or influenced by increased research capacity or experience. Significant professional development related to the projects also occurred with higher-level degrees being awarded, including 30 MScs, 30 PhDs, and nine postdoctoral fellowships. Through these projects, research capacity was strengthened across the region by equipping core research facilities, training research staff, strengthening research support services, and supporting the expansion of investigator networks. Conclusions: The completed Africa NCD Open Lab projects demonstrate high-quality research outcomes addressing important health challenges with potential benefits to African populations. Based on the success of the Africa NCD Open Lab, additional funding has been secured to extend the Open Lab initiative.

Macrovascular and renal microvascular complications in West Africans with intermediate hyperglycemia living in West Africa and Europe: The RODAM study.

Background: Metabolic conditions, including intermediate hyperglycemia (IH), affect migrants to a greater extent than the populations of origin. Evidence suggests that IH increases the risk of vascular complications, but it is unclear whether the differences in IH between the non-migrant and migrant populations translate to differences in vascular complications between the two populations. We compared the prevalence of macrovascular and renal microvascular complications among West Africans with IH living in West Africa and their migrant compatriots in Europe. Methods: Data from the multicenter Research on Obesity and Diabetes among African Migrants(RODAM) study were analyzed. Ghanaians with IH(524 non-migrant and 1439 migrants) were included. Logistic regression analyses were used to determine the associations between migrant status and macrovascular [coronary artery disease(CAD) and peripheral artery disease(PAD)] and renal microvascular[nephropathy] complications with adjustment for age, sex, socioeconomic status, smoking, systolic blood pressure, BMI, total cholesterol, HbA1c, C-reactive protein, and serum uric acid. Findings: The prevalence of microvascular/macrovascular complications was higher in non-migrants than in migrants(nephropathy 15.3vs.9.7%; PAD 3.1%vs.1.3%; and CAD 15.8% vs. 5.0%). The differences persisted in the fully adjusted model: nephropathy [odds ratio, 2.12; 95% CI(1.46-3.08); PAD, 4.44(1.87-10.51); CAD 2.35(1.64-3.37)]. Non-migrant females had higher odds of nephropathy[2.14(1.34-3.43)], PAD[7.47(2.38-23.40)] and CAD [2.10(1.34-3.27)] compared to migrant females. Non-migrant males had higher odds of nephropathy[2.54(1.30-4.97)] and CAD[2.85(1.48-5.50)], but not PAD[1.81(0.32-10.29)],than their migrant peers. Interpretation: Macrovascular and renal microvascular complications were more prevalent in non-migrants than in migrant West Africans with IH. Further studies are needed to identify factors that increase the risk to aid preventive/treatment strategies.

How chronic conditions are understood, experienced and managed within African communities in Europe, North America and Australia: A synthesis of qualitative studies.

This review focuses on the lived experiences of chronic conditions among African communities in the Global North, focusing on established immigrant communities as well as recent immigrant, refugee, and asylum-seeking communities. We conducted a systematic and narrative synthesis of qualitative studies published from inception to 2022, following a search from nine databases-MEDLINE, EMBASE, PsycINFO, Web of Science, Social Science Citation Index, Academic Search Complete, CINAHL, SCOPUS and AMED. 39 articles reporting 32 qualitative studies were included in the synthesis. The studies were conducted in 10 countries (Australia, Canada, Denmark, France, Netherlands, Norway, Sweden, Switzerland, United Kingdom, and the United States) and focused on 748 participants from 27 African countries living with eight conditions: type 2 diabetes, hypertension, prostate cancer, sickle cell disease, chronic hepatitis, chronic pain, musculoskeletal orders and mental health conditions. The majority of participants believed chronic conditions to be lifelong, requiring complex interventions. Chronic illness impacted several domains of everyday life-physical, sexual, psycho-emotional, social, and economic. Participants managed their illness using biomedical management, traditional medical treatment and faith-based coping, in isolation or combination. In a number of studies, participants took 'therapeutic journeys'-which involved navigating illness action at home and abroad, with the support of transnational therapy networks. Multi-level barriers to healthcare were reported across the majority of studies: these included individual (changing food habits), social (stigma) and structural (healthcare disparities). We outline methodological and interpretive limitations, such as limited engagement with multi-ethnic and intergenerational differences. However, the studies provide an important insights on a much-ignored area that intersects healthcare for African communities in the Global North and medical pluralism on the continent; they also raise important conceptual, methodological and policy challenges for national health programmes on healthcare disparities.

Living with tuberculosis: a qualitative study of patients' experiences with disease and treatment.

BACKGROUND: Although tuberculosis (TB) is a curable disease, treatment is complex and prolonged, requiring considerable commitment from patients. This study aimed to understand the common perspectives of TB patients across Brazil, Russia, India, China, and South Africa throughout their disease journey, including the emotional, psychological, and practical challenges that patients and their families face. METHODS: This qualitative market research study was conducted between July 2020 and February 2021. Eight TB patients from each country (n = 40) completed health questionnaires, video/telephone interviews, and diaries regarding their experiences of TB. Additionally, 52 household members were interviewed. Patients at different stages of their TB treatment journey, from a range of socioeconomic groups, with or without TB risk factors were sought. Anonymized data underwent triangulation and thematic analysis by iterative coding of statements. RESULTS: The sample included 23 men and 17 women aged 13-60 years old, with risk factors for TB reported by 23/40 patients. Although patients were from different countries and cultural backgrounds, experiencing diverse health system contexts, five themes emerged as common across the sample. 1) Economic hardship from loss of income and medical/travel expenses. 2) Widespread stigma, delaying presentation and deeply affecting patients' emotional wellbeing. 3) TB and HIV co-infection was particularly challenging, but increased TB awareness and accelerated diagnosis. 4) Disruption to family life strained relationships and increased patients' feelings of isolation and loneliness. 5) The COVID-19 pandemic made it easier for TB patients to keep their condition private, but disrupted access to services. CONCLUSIONS: Despite disparate cultural, socio-economic, and systemic contexts across countries, TB patients experience common challenges. A robust examination of the needs of individual patients and their families is required to improve the patient experience, encourage adherence, and promote cure, given the limitations of current treatment.

Comparison of 8 weeks standard treatment (rifampicin plus clarithromycin) vs. 4 weeks standard plus amoxicillin/clavulanate treatment [RC8 vs. RCA4] to shorten Buruli ulcer disease therapy (the BLMs4BU trial): study protocol for a randomized controlled multi-centre trial in Benin.

BACKGROUND: Buruli ulcer (BU) is a neglected tropical disease caused by Mycobacterium ulcerans that affects skin, soft tissues, and bones, causing long-term morbidity, stigma, and disability. The recommended treatment for BU requires 8 weeks of daily rifampicin and clarithromycin together with wound care, physiotherapy, and sometimes tissue grafting and surgery. Recovery can take up to 1 year, and it may pose an unbearable financial burden to the household. Recent in vitro studies demonstrated that beta-lactams combined with rifampicin and clarithromycin are synergistic against M. ulcerans. Consequently, inclusion of amoxicillin/clavulanate in a triple oral therapy may potentially improve and shorten the healing process. The BLMs4BU trial aims to assess whether co-administration of amoxicillin/clavulanate with rifampicin and clarithromycin could reduce BU treatment from 8 to 4 weeks. METHODS: We propose a randomized, controlled, open-label, parallel-group, non-inferiority phase II, multi-centre trial in Benin with participants stratified according to BU category lesions and randomized to two oral regimens: (i) Standard: rifampicin plus clarithromycin therapy for 8 weeks; and (ii) Investigational: standard plus amoxicillin/clavulanate for 4 weeks. The primary efficacy outcome will be lesion healing without recurrence and without excision surgery 12 months after start of treatment (i.e. cure rate). Seventy clinically diagnosed BU patients will be recruited per arm. Patients will be followed up over 12 months and managed according to standard clinical care procedures. Decision for excision surgery will be delayed to 14 weeks after start of treatment. Two sub-studies will also be performed: a pharmacokinetic and a microbiology study. DISCUSSION: If successful, this study will create a new paradigm for BU treatment, which could inform World Health Organization policy and practice. A shortened, highly effective, all-oral regimen will improve care of BU patients and will lead to a decrease in hospitalization-related expenses and indirect and social costs and improve treatment adherence. This trial may also provide information on treatment shortening strategies for other mycobacterial infections (tuberculosis, leprosy, or non-tuberculous mycobacteria infections). TRIAL REGISTRATION: ClinicalTrials.gov NCT05169554 . Registered on 27 December 2021.

Psychosocial stressors among Ghanaians in rural and urban Ghana and Ghanaian migrants in Europe.

Psychosocial stressors have significant health and socio-economic impacts on individuals. We examined the prevalence and correlates of psychosocial stressors among non-migrant and migrant Ghanaians as there is limited research in these populations. The study was cross-sectional and quantitative in design. A majority of the study participants had experienced stress, discrimination and negative life events. Increased age, female sex, strong social support and high sense of mastery were associated with lower odds of experiencing psychosocial stressors in both populations. Interventions should be multi-level in design, focusing on the correlates which significantly influence the experience of psychosocial stressors.

Serum potassium concentration and its association with hypertension among Ghanaian migrants and non-migrants: The RODAM study.

BACKGROUND AND AIMS: Low serum potassium concentration is associated with hypertension, but whether the same association can be found in African origin populations, is unknown. We assessed serum potassium concentration, and its association with hypertension among Ghanaians living in different geographical locations. METHODS: Baseline data of 962 rural, 1420 urban, and 2947 migrant Ghanaians from the Research on Obesity and Diabetes among African Migrants study were analysed. Mean serum potassium concentration was compared between the groups, and the association between serum potassium and hypertension was assessed using multivariate regression analyses. RESULTS: Mean serum potassium concentration was higher in rural Ghana (4.28, 95% confidence interval 4.25-4.32 mmol/L) than in Ghanaians living in Amsterdam (3.90, 3.88-3.92 mmol/L) and London (4.11, 4.07-4.14 mmol/L), but lower than in Ghanaians living in urban Ghana (4.38, 4.34-4.42 mmol/L) and Berlin (4.57, 4.51-4.62 mmol/L) in both sexes. In the age-adjusted analyses, serum potassium was associated with hypertension in urban- (odds ratio 0.44, 0.23-0.82), London- (0.34, 0.17-0.64) and Amsterdam-Ghanaian males (0.41, 0.20-0.86), and in rural- (0.49, 0.28-0.84), London- (0.29, 0.17-0.49) and Amsterdam-Ghanaian females (0.33, 0.17-0.64). However, after adjustment for demographic, lifestyle, and health factors, serum potassium was associated with hypertension in Amsterdam-Ghanaian males only (0.12, 0.02-0.59). CONCLUSIONS: This study shows differences in mean serum potassium among Ghanaian populations living in different locations in Europe and Ghana, and different associations with hypertension between sites. Further research should focus on elucidating the mechanism underlying potassium handling and blood pressure regulation in African populations, in order to mitigate the burden of hypertension among these populations.

The Magnitude and Directions of the Associations between Early Life Factors and Metabolic Syndrome Differ across Geographical Locations among Migrant and Non-Migrant Ghanaians-The RODAM Study.

BACKGROUND: Early-life factors (ELFs) such as childhood nutrition and childhood socio-economic status could be the drivers of the increase in metabolic syndrome (MetSyn) among African populations, but data are lacking. This study evaluated whether markers of childhood nutritional status and childhood socio-economic status were associated with MetSyn in adulthood among migrant Ghanaians living in Europe and non-migrant Ghanaians living in Ghana. METHODS: Data from the Research on Obesity and Diabetes among African Migrants (RODAM) study, involving 2008 migrants and 2320 non-migrants aged ≥25 years, were analysed for this study. We used leg-length to height ratio (LHR), which is an anthropometric marker of childhood nutritional status, and parental education, which is a marker of childhood socio-economic status, as proxies. Adjusted odds ratios (AOR) and 95% confidence intervals (95% CI) were calculated by logistic regression with adjustments for demographic and lifestyle factors. RESULTS: Parental education was higher among Ghanaians in Europe than among residents in rural and urban Ghana. The prevalence of MetSyn was 18.5%, 27.7% and 33.5% for rural, urban, and migrant residents, respectively. LHR was inversely associated with MetSyn among migrants. Compared with high paternal education, individuals with low paternal education had lower odds of MetSyn in migrants (AOR 0.71 95% CI 0.54-0.94). In contrast, compared with high maternal education, individuals with intermediate maternal education had higher odds of MetSyn in urban Ghanaians (AOR 4.53 95% CI 1.50-3.74). No associations were found among rural Ghanaians. CONCLUSION: The magnitude and direction of the associations between ELFs and MetSyn differ across geographical locations. Intermediate maternal education was positively associated with MetSyn among urban Ghanaians, while LHR and low paternal education were inversely associated with MetSyn among migrant Ghanaians. Further research into the interplay of genetics, environment and behaviour is needed to elucidate the underlying pathological mechanisms of MetSyn amongst migrants.

Association between Practising Religion and Cardiovascular Disease Risk among Ghanaian Non-Migrants and Migrants in Europe: The RODAM Study.

(1) Background: Sub-Saharan African migrants residing in high-income countries are more affected by cardiovascular diseases (CVDs) and associated risk factors than host populations for unclear reasons. The aim was to explore the associations of religion and religious affiliations with CVD risk among Ghanaian non-migrants and migrants in Europe. (2) Methods: The 10-year CVD risk was estimated using pooled cohort equations for 3004 participants from the cross-sectional Research on Obesity and Diabetes among African Migrants (RODAM) study. Logistic regression analyses were conducted to assess associations between religion and elevated CVD risk (score ≥ 7.5) with adjustment for covariates. (3) Results: Religious men in Europe had a lower 10-year CVD risk compared with non-religious men (adjusted OR 0.51; 95% confidence interval 0.30-0.85), specifically men affiliated with Seventh-Day Adventism (0.24; 0.11-0.53) followed by other affiliations (0.32; 0.11-0.94) and Roman Catholicism (0.42; 0.21-0.86). The opposite was found in Ghana, with religious women having higher odds for elevated 10-year CVD risk (1.53; 1.02-2.30) compared with their non-religious counterparts, specifically women affiliated with Reformed Christianity (1.73; 1.03-2.90) and other denominations (2.81; 1.20-6.54). Associations were not significant for men in Ghana and women in Europe. Adjustments for social support, stress, and health behaviors did not meaningfully alter the associations. (4) Conclusions: Christian religious Ghanaian men living in Europe seem to have lower CVD risk compared with their non-religious counterparts, while Christian religious women in Ghana appear to have increased CVD risk. Further unravelling the contributing factors and the differences between sex and environmental settings is needed.

Anthropometric indices and their cut-off points in relation to type 2 diabetes among Ghanaian migrants and non-migrants: The RODAM study.

AIMS: To compare body mass index (BMI), waist circumference (WC) and waist-to-hip ratio (WHR) as determinants of type 2 diabetes (T2DM) and determine optimal cut-offs in a sub-Saharan African population. METHODS: Data from the RODAM study including Ghanaians aged 25-70 living in rural Ghana, urban Ghana and Europe were used. Logistic regression was used to assess associations between BMI, WC, WHR and T2DM status, by sex and site. Area under the curve (AUC) were constructed to discriminate between indices and establish performance and cut-off values. RESULTS: WHR had the strongest association with T2DM in men and women across sites, except for rural men. The highest adjusted odds ratio (aOR) and AUC were in rural women for WHR (aOR = 2.09, 95%CI = 1.47-2.99; AUC = 0.71). Among migrants, WHR had higher AUCs compared with BMI (p < 0.01) and WC (p < 0.05). Cut-offs for BMI and WC in men were lower compared with the WHO reference across sites (WC: 85.4-93.7 vs 102 cm, BMI: 23.1-28.2 vs 30.0 kg/m2). CONCLUSIONS: WHR outperformed BMI and WC as anthropometric indices in relation to T2DM among Ghanaian migrants. The lower BMI and WC cut-offs for T2DM than WHO established standards, highlights the need for African specific cut-offs to avoid missing high risk populations.

Rationale, design and protocol of a cross-sectional study on pregnancy-related cardiovascular diseases in Tanzania (PRECARDT): burden, characterisation and prognostic significance at delivery.

INTRODUCTION: The paucity of data describing cardiovascular disease (CVD) in pregnancy in many parts of Africa including Tanzania has given rise to challenges in proper management by the healthcare providers. This study is set out to (1) determine the prevalence of a range of CVDs during pregnancy in women attending antenatal clinics in Tanzania and (2) determine the impact of these CVDs on maternal and fetal outcomes at delivery. METHODS AND ANALYSIS: This is a cross-sectional study with a prospective component to be conducted in two referral hospitals in Tanzania. Pregnant women aged ≥18 years diagnosed with a CVD during the antenatal period are being identified and extensively characterised by performing clinical assessment, modified WHO staging, electrocardiography, echocardiography and laboratory tests. Patients identified with CVDs (exposed) and a subset without (unexposed) will be followed up to determine maternal and fetal outcomes at delivery. A minimum sample of 1560 will be sufficient to estimate the prevalence of CVDs with a 95% CI of 2.75% to 5.25%. ETHICS AND DISSEMINATION: The study is being conducted in accordance with the Helsinki declaration on studies involving human subjects. Ethical approvals have been obtained from Muhimbili University (reference number DA.282/298/01.C/) and Bugando Medical Centre (reference number CREC/330/2019) Ethics Committees. Informed consent is sought from all potential participants before any interview or investigations are performed. Study findings will be disseminated to the scientific community through different methods. Results will also be communicated to policymakers and to the public, as appropriate.

Physical Inactivity among Ghanaians in Ghana and Ghanaian Migrants in Europe.

PURPOSE: There is a paucity of data on physical activity (PA) among migrants from sub-Saharan Africa, yet physical inactivity is a key risk factor for noncommunicable diseases. We examined the levels of physical inactivity and its determinants among Ghanaians in different geographical locations. METHODS: We used the Research on Obesity and Diabetes among African Migrants data of Ghanaian adults (n = 4760) age 25-70 yr in rural and urban Ghana and three European cities (Amsterdam, London, and Berlin). Using total physical activity metabolic equivalent of task, physical inactivity was defined as total physical activity metabolic equivalent of task minutes per week less than 600. Logistic regression was used to examine the differences in the levels and the determinants of physical inactivity across sites. RESULTS: Physical inactivity was higher among Ghanaian migrants (14.6% in Amsterdam, 24.1% in Berlin, and 36.6% in London) and urban Ghanaians (29.0%) compared with rural Ghanaians (11.2%). After adjustment for covariates (age, sex, education, health status, smoking status, body mass index, and social network) using rural Ghanaians as the comparator group, the odds ratios for physical inactivity in men ranged from 3.67 (95% confidence interval, 2.19-6.16) in urban Ghanaians to 10.37 (5.96-18.02) in London Ghanaians, and from 3.27 (2.46-4.35) in urban Ghanaians to 4.41 (3.12-6.22) in London Ghanaians in women. Migrants in London and Berlin had higher odds of physical inactivity compared with Amsterdam. Increased age, university education, and overweight/obesity were positively associated with physical inactivity, whereas social support was inversely associated with physical inactivity with variability across sites. CONCLUSIONS: Findings indicate high prevalence of physical inactivity among Ghanaians in all sites, particularly among Ghanaians in Europe. Hence, there is the need to take local context into account to improve PA.

Early-life exposures and cardiovascular disease risk among Ghanaian migrant and home populations: the RODAM study.

Early-life environmental and nutritional exposures are considered to contribute to the differences in cardiovascular disease (CVD) burden. Among sub-Saharan African populations, the association between markers of early-life exposures such as leg length and sitting height and CVD risk is yet to be investigated. This study assessed the association between leg length, sitting height, and estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk among Ghanaian-born populations in Europe and Ghana. We constructed sex-specific quintiles for sitting height and leg length for 3250 participants aged 40-70 years (mean age 52 years; men 39.6%; women 60.4%) in the cross-sectional multicenter Research on Diabetes and Obesity among African Migrants study. Ten-year risk of ASCVD was estimated using the Pooled Cohort Equations; risk ≥7.5% was defined as "elevated" CVD risk. Prevalence ratios (PR) were estimated to determine the associations between sitting height, leg length, and estimated 10-year ASCVD risk. For both men and women, mean sitting height and leg length were highest in Europe and lowest in rural Ghana. Sitting height was inversely associated with 10-year ASCVD risk among all women (PR for 1 standard deviation increase of sitting height: 0.75; 95% confidence interval: 0.67, 0.85). Among men, an inverse association between sitting height and 10-year ASCVD risk was significant on adjustment for study site, adult, and parental education but attenuated when further adjusted for height. No association was found between leg length and estimated 10-year ASCVD risk. Early-life and childhood exposures that influence sitting height could be the important determinants of ASCVD risk in this adult population.

Differential associations between psychosocial stress and obesity among Ghanaians in Europe and in Ghana: findings from the RODAM study.

PURPOSE: Psychosocial stress is associated with obesity in some populations, but it is unclear whether the association is related to migration. This study explored associations between psychosocial stress and obesity among Ghanaian migrants in Europe and non-migrant Ghanaians in Ghana. METHODS: Cross-sectional data from the RODAM study were used, including 5898 Ghanaians residing in Germany, the UK, the Netherlands, rural Ghana, and urban Ghana. Perceived discrimination, negative life events and stress at work or at home were examined in relation to body mass index (BMI) and waist circumference (WC). Linear regression analyses were performed separately for migrants and non-migrants stratified by sex. RESULTS: Perceived discrimination was not associated with BMI and WC in both migrants and non-migrants. However, negative life events were positively associated with BMI (ß = 0.78, 95% CI 0.34-1.22) and WC (ß = 1.96, 95% CI 0.79-3.12) among male Ghanaian migrants. Similarly, stress at work or at home was positively associated with BMI (ß = 0.28, 95% CI 0.00-0.56) and WC (ß = 0.84, 95% CI 0.05-1.63) among male Ghanaian migrants. Among non-migrant Ghanaians, in contrast, stress at work or at home was inversely associated with BMI and WC in both males (ß = - 0.66, 95% CI - 1.03 to - 0.28; ß = - 1.71 95% CI - 2.69 to - 0.73, respectively) and females (ß = - 0.81, 95% CI - 1.20 to - 0.42; ß = - 1.46, 95% CI - 2.30 to - 0.61, respectively). CONCLUSIONS: Negative life events and stress at work or at home are associated with increased body weight among male Ghanaians in European settings, whereas stress at work or at home is associated with reduced body weight among Ghanaians in Ghana. More work is needed to understand the underlying factors driving these differential associations to assist prevention efforts.

Prospective exploration of the effect of adiposity and associated microbial factors on healing and progression of diabetic foot ulcers in Tanzania: study protocol of a longitudinal cohort study.

BACKGROUND: Diabetic foot ulcers (DFUs) are associated with high morbidity and mortality in low-income countries. This coexists with an increasing prevalence of obesity which has been reported to alter antimicrobial susceptibility and potentially affect the outcome of infected foot ulcers. This study aims to determine whether adiposity and local microbial factors affect the progression and healing of foot ulcers in people with type 2 diabetes in hospital settings in Tanzania. METHODS AND ANALYSIS: A prospective cohort of 300 individuals with type 2 diabetes presenting with DFUs at an outpatient clinic will be enrolled into the study. At baseline, participants will be stratified into normal and high adiposity groups (150 per group) as measured by bioelectrical impedance analysis (BIA). Both groups will receive DFU management according to locally appropriate standards of care and will be followed up for 24 weeks or until complete wound healing, whichever occurs first. The primary end point is complete wound healing at 24 weeks while secondary end points are ulcer progression (worsening or improving), amputation and death. Enrolling 150 participants per group will have a minimum power of 80% to detect a 20% difference in cumulative incidence of complete ulcer healing (at the 5% level of statistical significance) between the normal and high adiposity groups. ETHICAL CONSIDERATIONS AND DISSEMINATION OF RESULTS: This study will be conducted in compliance with the independent institutional review boards (IRBs), informed consent guidelines, the declaration of Helsinki and International Conference on Harmonisation, Good Clinical Practice Guidelines. Ethical clearance has been granted by the Muhimbili University of Health and Allied Sciences ethical review board (MUHAS Ref. No. DA.282/298/01 .C/). Permissions to conduct the study have been granted by the Abbas Medical Centre and the Muhimbili Academic Medical Centre (MAMC).Progress and results emanating from this work will be communicated to the scientific community through conference presentations, short communications (using journal letters and interesting case reports) and peer-reviewed publications. When necessary, through proper channels, popular means of communication (newspapers, magazines and online communications) will be used to inform policy and the public. TRIAL REGISTRATION NUMBER: NCT03960255; Pre-results.

Prevalence and determinants of type 2 diabetes among lean African migrants and non-migrants: the RODAM study.

BACKGROUND: Exposure to adverse conditions earlier in life-course can predispose to type 2 diabetes in adulthood, irrespective of body mass index (BMI). However, the burden of type 2 diabetes in lean Africans is not well understood despite higher exposure to adverse early life conditions. Mirroring ongoing epidemiological transition, we assessed the burden and determinants of type 2 diabetes in a homogenous group of lean Ghanaians residing in rural and urban Ghana, and as migrants in Europe. METHODS: Baseline data from 2179 RODAM study participants with BMI<25kg/m2 (25-70 years) were analyzed. Prevalence and determinants of type 2 diabetes were estimated using logistic regression analysis. Adjustments were made for socio-demographic and lifestyle factors, use of anti-diabetic medication and optimal blood glucose control. RESULTS: Prevalence of type 2 diabetes in rural, urban and migrant lean participants were 3.5%, 8.9% and 7.5% respectively, representing 55.4%, 35.6%, 13.2% of all participants with type 2 diabetes. Compared with lean rural participants, the odds of type 2 diabetes were higher in lean urban participants (adjusted OR = 8.81, 95% CI = 6.56-11.06), followed by migrants (5.27, 95% CI = 3.51-6.91). Irrespective of site, determinants of type 2 diabetes in lean participants include; presence of hypertension, physical inactivity, hypercholesterolemia and age (>45 years). CONCLUSIONS: Our study shows a high prevalence of type 2 diabetes among lean African populations in different geographical settings. Future studies are needed in-order to examine how contextual differences are related to the pathophysiology of type 2 diabetes in lean individuals.

Psychosocial factors and hypertension prevalence among Ghanaians in Ghana and Ghanaian migrants in Europe: The RODAM study.

Despite progress made to prevent and control hypertension, its prevalence has persisted in many countries. This study examined the associations between psychosocial factors and hypertension among Ghanaian non-migrants and migrants. Data were drawn from the Research on Obesity and Diabetes among African Migrants (RODAM) project. Findings show that among migrant women, those who experienced periods of stress at home/work had higher odds of hypertension. Among non-migrants, women with depression symptoms were more likely to be hypertensive. Furthermore, there was a positive association between negative life events and hypertension among non-migrant men. The findings highlight the importance of psychosocial factors in addressing hypertension prevalence in Ghanaian populations.

Cross-sectional study of association between psychosocial stressors with chronic kidney disease among migrant and non-migrant Ghanaians living in Europe and Ghana: the RODAM study.

OBJECTIVES: The association between psychosocial stressors (PS) and chronic kidney disease (CKD) among sub-Saharan African (SSA) populations is unknown. We examined the association between PS and CKD prevalence among rural and urban Ghanaians and Ghanaian migrants living in three European cities. We also assessed if the influence of PS on CKD is partially mediated by primary risk factors (hypertension and diabetes) of CKD. DESIGN: A multi-centred cross sectional data from the Research on Obesity and Diabetes among African Migrants study. SETTING: Rural and urban Ghana and three European cities (Amsterdam, Berlin and London). PARTICIPANTS: A random sample of 5659 adults (Europe 3167, rural Ghana 1043 and urban Ghana 1449) aged 25-70 years. EXPLANATORY MEASURES: PS defined by negative life events, perceived discrimination, perceived stress at work/home and depressive symptoms. Three CKD outcomes were considered using the 2012 Kidney Disease: Improving Global Outcomes severity of CKD classification. Comparisons between PS and CKD outcomes were made using logistic regression analyses across all sites. RESULTS: We observed higher proportion of negative life events (68.7%) and perceived permanent stress (15.9%) among Ghanaians living in Ghana than Ghanaians living in Europe. Depressive symptoms (7.5%) and perceived discrimination (29.7%) were more common among Ghanaians living in Europe than Ghanaians living in Ghana. No significant association was observed between any of the PS constructs and CKD outcomes across sites except for positive association between stress at work/home and albuminuria (2.81, 95% CI 1.46 to 5.40) and CKD risk (2.78, 95% CI 1.43 to 5.43) among Ghanaians living in Berlin. CONCLUSION: Our study found a positive association between stress at work/home and albuminuria and CKD risk. There was no convincing evidence of associations between the other PS constructs and the prevalence of CKD risk. Further studies are needed to identify potential factors driving the high prevalence of CKD among these populations.

Non-communicable diseases in sub-Saharan Africa: a scoping review of large cohort studies.

BACKGROUND: Non-communicable diseases (NCDs) cause a large and growing burden of morbidity and mortality in sub-Saharan Africa. Prospective cohort studies are key to study multiple risk factors and chronic diseases and are crucial to our understanding of the burden, aetiology and prognosis of NCDs in SSA. We aimed to identify the level of research output on NCDs and their risk factors collected by cohorts in SSA. METHODS: We conducted a scoping review to map the extent of current NCDs research in SSA by identifying studies published after the year 2000 using prospectively collected cohort data on any of the six NCDs (cardiovascular diseases, diabetes, obesity, chronic kidney disease, chronic respiratory diseases, and cancers), ≥1 major risk factor (other than age and sex), set only within SSA, enrolled ≥500 participants, and ≥12 months of follow-up with ≥2 data collection points (or with plans to). We performed a systematic search of databases, a manual search of references lists from included articles and the INDEPTH network website, and study investigators from SSA were contacted for further articles. RESULTS: We identified 30 cohort studies from the 101 included articles. Eighteen countries distributed in West, Central, East and Southern Africa, were represented. The majority (27%) set in South Africa. There were three studies including children, twenty with adults, and seven with both. 53% of cohorts were sampled in general populations, 47% in clinical populations, and 1 occupational cohort study. Hypertension (n = 23) was most commonly reported, followed by obesity (n = 16), diabetes (n = 15), CKD (n = 6), COPD (n = 2), cervical cancer (n = 3), and breast cancer (n = 1). The majority (n = 22) reported data on at least one demographic/environmental, lifestyle, or physiological risk factor but these data varied greatly. CONCLUSIONS: Most studies collected data on a combination of hypertension, diabetes, and obesity and few studies collected data on respiratory diseases and cancer. Although most collected data on different risk factors the methodologies varied greatly. Several methodological limitations were found including low recruitment rate, low retention rate, and lack of validated and standardized data collection. Our results could guide potential collaborations and maximize impact to improve our global understanding of NCDs (and their risk factors) in SSA and also to inform future research, as well as policies.

Early-life factors are associated with waist circumference and type 2 diabetes among Ghanaian adults: The RODAM Study.

Early-life experiences may fuel the emergence of obesity and type 2 diabetes among African populations. We evaluated childhood socio-economic status (SES) and childhood nutritional status as risk factors for increased waist circumference and type 2 diabetes among Ghanaian adults. In the multi-center, cross-sectional Research on Obesity and Diabetes among African Migrants (RODAM) Study, we calculated associations (adjusted for demographics and lifestyle) of parental education and anthropometric markers of childhood nutrition [leg length, leg length-to-height ratio (LHR)] with waist circumference and type 2 diabetes, respectively. Among 5,575 participants (mean age: 46.2 years; 62% female), lower education of either parent (vs. higher) was consistently associated with higher waist circumference (∆: 1.6-3.4 cm). Lower father's education tended to increase the odds of type 2 diabetes by 50% in women (95% confidence interval (CI): 1.0, 2.4). Reduced leg length and LHR were associated with higher waist circumference. But only in men, leg length was inversely related to type 2 diabetes (OR per 1 standard deviation decrease: 1.1; 95% CI: 1.0, 1.3). In this study, markers of poor childhood SES and early-life nutritional status relate to abdominal obesity in men and women and to type 2 diabetes in men. Thus, prevention efforts should start in early childhood.