Very-low-calorie diet-based intensive lifestyle intervention for remission of type 2 diabetes: Real-world experience in a South Asian population.

AIMS: Very low-calorie diet (VLCD) can induce weight loss and diabetes remission (DR) amongst people with obesity and recent-onset type 2 diabetes (T2D). We aimed to determine the effectiveness and acceptability of VLCD in achieving DR amongst Sri Lankan adults with T2D. METHODS: A retrospective analysis was conducted in a diabetes practice where VLCD-based Diabetes Remission Programme (VDRP) was offered for adults (>18 years) with T2D for <3 years and body mass index over 25 kg/m2. VLCD (~800 kcal/day, provided with/without diet replacement formula) was offered for 8-12 weeks, followed by gradual food reintroduction and exercise. DR was defined as HbA1c <6.5% at least 3 months after stopping glucose-lowering medications. RESULTS: A total of 170 participants who enrolled in the VDRP (mean age 38.4 years [±11.1], men 68%, mean baseline HbA1c 86.9 [±18.1] mmol/mol (10.1 [±2.1]%), median duration of T2D 2 years [IQR 1-2]) and 87 (51%) of them followed the programme (attended at least one follow-up visit). Amongst the individuals who followed the VDRP, 40.2% achieved DR (35/87), compared with 2.4% (2/83) amongst those who did not follow the VDRP (aHR 9.3, 95% CI 2.2-16.4, p = 0.002). The proportion achieving normoglycaemia (HbA1c < 6.5%) but continued to take glucose-lowering medication was 20/87 among VDRP followers and 20/85 amongst VDRP non-followers. The commonest reasons for not following the VDRP were too restrictive dietary quantity (92%) and difficulties in finding recommended food items (67%). Majority (79%) would recommend VDRP to others. CONCLUSIONS: VDRP is effective in achieving T2D remission amongst Sri Lankan adults with recently diagnosed T2D and obesity. Over half of the participants followed the programme and over 75% would recommend it to others, indicating good acceptability.

Plasma glucose in screening for diabetes and pre-diabetes: how much is too much? Analysis of fasting plasma glucose and oral glucose tolerance test in Sri Lankans.

BACKGROUND: Fasting plasma glucose (FPG) is the most commonly used screening tool for diabetes in Sri Lanka. Cut-off values from American Diabetes Association recommendations are adopted in the absence of local data. We aimed to establish FPG cut offs for Sri Lankans to screen for diabetes and pre-diabetes. METHODS: Data on FPG and diabetes/pre-diabetes status were obtained from Sri Lanka Diabetes and Cardiovascular Study (SLDCS), a community based island wide observational study conducted in 2005-6. Sensitivity specificity and area under the ROC curve were calculated for different FPG values. RESULTS: Study included 4014 community dwelling people after excluding people already on treatment for diabetes or pre-diabetes. Mean age was 45.3 (± 15) years and 60.4% were females. FPG cut off of 5.3 mmol/L showed better sensitivity and specificity than 5.6 mmol/L in detecting diabetes (87.8% and 84.4% Vs 80.8% and 92.1%) and pre-diabetes (54.7% and 87.0% Vs 43.8% and 94.2%). CONCLUSIONS: A lower FPG cut off of 5.3 mmol/L has a better sensitivity and acceptable specificity in screening for diabetes and pre-diabetes in Sri Lankan adults.

Hypoglycaemia in diabetes: do we think enough of the cause? An observational study on prevalence and causes of hypoglycaemia among patients with type 2 diabetes in an out-patient setting in Sri Lanka.

BACKGROUND: Hypoglycaemia is a feared experience for people with diabetes. We aimed to study the prevalence and causes of hypoglycaemia among Sri Lankans with diabetes. METHODS: One thousand patients with diabetes attending a private sector diabetic clinic were interviewed using a structured questionnaire. Hypoglycaemic episodes within the preceding month were inquired and severity was graded according to clinical features and/or capillary blood glucose levels. RESULTS: Mean age 55.0 years (± 12.5), 58.6% were males, mean diabetes duration 10.6 years (± 8.1), mean FPG 7.48 mmol/l (± 2.79) and mean HbA1c 7.82% (± 1.71) (62 mmol/mol). Of them, 26.1%. (mild 20.7%, moderate 3.9%, and severe 1.5%) experienced symptomatic hypoglycaemia. Sudden change diet (46.7%), unaccustomed exercise (15.7%) and increase in antihyperglycaemic therapy dosage (14.9%) were the recognized causes. Cause was not recognized by 16.3%. Non-prescribed native food items accounted for hypoglycaemia in 16.9% of patients (Momordica charantia 54.5%, Costus speciosus 52.3%, Salacia prinoides 11.4%, Coccinia grandis 6.8%, Adenanthera pavonina 4.5%). Severity of hypoglycaemia was positively correlated to age and duration of diabetes but not to HbA1C. CONCLUSION: Hypoglycaemia is common among patients with diabetes. Patients need advice on regular diet and exercise. Consumption of non-prescribed native foods should be considered as a possible cause.

Study protocol: a randomised controlled trial of supervised resistance training versus aerobic training in Sri Lankan adults with type 2 diabetes mellitus: SL-DART study.

BACKGROUND: The prevalence of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD) is rising globally. T2DM is particularly problematic in South Asia with an estimated 10-15% of Sri Lankans diagnosed with the disease. Exercise is known to improve blood glucose, lipid profiles, blood pressure and adiposity, key goals in the management of T2DM. However, much of the evidence to date has been gained from white Caucasians who have a different body composition and disease profile compared to South Asians. Similarly, the recreational exercise culture is new to Sri Lankans and the effects of exercise on T2DM has not been studied in this population. METHODS: The Sri Lanka Diabetes Aerobic and Resistance Training (SL-DART) Study will be comprised of 2 components. Component 1 is a 12-week randomized controlled trial (RCT) to compare the effects of a supervised progressive resistance exercise program (RT) and aerobic exercise program (AT) with standard treatment/control (CN). Sedentary Sri Lankan adults with T2DM (aged 35-65 years) and with no contraindications to exercise will be randomized into one of 3 groups (AT, RT, CN). Exercise sessions will be conducted 2 days/week for 3 months. Baseline and post-intervention biochemical (glycemic control, lipid and liver profiles, inflammatory markers), anthropometric (height, weight, body circumferences), body composition, physical fitness, food preference (liking and wanting food) and quality of life parameters will be measured and compared between groups. Component 2 will be a qualitative study conducted immediately post-intervention via in-depth interviews to assess the barriers and facilitators for adherence to each exercise program. DISCUSSION: SL-DART Study represents one of the first adequately powered methodologically sound RCTs conducted in South Asia to assess the effects of resistance and aerobic exercise in participants with T2DM. Triangulation of quantitative and qualitative outcomes will enable the design of a culturally appropriate therapeutic physical activity intervention for Sri Lankans with T2DM, and the initiation of a professionally driven and specialized clinical exercise prescription service. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry; SLCTR/2016/017 . Date registered 17.06.2016. Universal trial number U1111-1181-7561.

Development and validation of a Diabetes Risk Score for screening undiagnosed diabetes in Sri Lanka (SLDRISK).

BACKGROUND: Screening for undiagnosed diabetes is not widely undertaken due to the high costs and invasiveness of blood sampling. Simple non-invasive tools to identify high risk individuals can facilitate screening. The main objectives of this study are to develop and validate a risk score for screening undiagnosed diabetes among Sri Lankan adults and to compare its performance with the Cambridge Risk Score (CRS), the Indian Diabetes Risk Score (IDRS) and three other Asian risk scores. METHODS: Data were available from a representative sample of 4276 adults without diagnosed diabetes. In a jack-knife approach two thirds of the sample was used for the development of the risk score and the remainder for the validation. Age, waist circumference, BMI, hypertension, balanitis or vulvitis, family history of diabetes, gestational diabetes, physical activity and osmotic symptoms were significantly associated with undiagnosed diabetes (age most to osmotic symptoms least). Individual scores were generated for these factors using the beta coefficient values obtained in multiple logistic regression. A cut-off value of sum = 31 was determined by ROC curve analysis. RESULTS: The area under the ROC curve of the risk score for prevalent diabetes was 0.78 (CI 0.73-0.82). In the sample 36.3 % were above the cut-off of 31. A risk score above 31 gave a sensitivity, specificity, positive predictive value and negative predictive value of 77.9, 65.6, 9.4 and 98.3 % respectively. For Sri Lankans the AUC for the CRS and IDRS were 0.72 and 0.66 repectively. CONCLUSIONS: This simple non-invasive screening tool can identify 80 % of undiagnosed diabetes by selecting 40 % of Sri Lankan adults for confirmatory blood investigations.

The influence of family history of diabetes on disease prevalence and associated metabolic risk factors among Sri Lankan adults.

AIMS: To describe the influence of family history on diabetes prevalence and associated metabolic risk factors in a nationally representative sample from Sri Lanka. METHODS: A cross sectional national survey was conducted among 5000 adults in Sri Lanka. Family history was evaluated at three levels: (1) parents, (2) grandparents (paternal and maternal) and (3) siblings. A binary-logistic regression analysis controlling for confounders (age, gender, BMI and physical activity) was performed in all patients with 'presence of diabetes' as the dichotomous dependent variable and using family history in father, mother, maternal grandmother/grandfather, paternal grandmother/grandfather, siblings and children as binary independent variables. RESULTS: The sample size was 4485, mean age was 46.1 ± 15.1 years and 39.5% were males. In all adults, the prevalence of diabetes was significantly higher in patients with a family history (23.0%) than those without (8.2%) (P < 0.001). When family history was present in both parents, the prevalence of diabetes was 32.9%. Presence of a family history significantly increased the risk of diabetes [odds ratio (OR): 3.35, 95% confidence interval (CI): 2.78-4.03], obesity (OR: 2.45, 95% CI: 1.99-2.99), hypertension (OR: 1.25, 95% CI: 1.08-1.45) and metabolic syndrome (OR: 2.28, 95% CI: 1.97-2.63). In all adults, the presence of a family history of diabetes in a father (OR: 1.29, 95% CI: 1.02-1.63), mother (OR: 1.23, 95% CI: 1.11-1.36), paternal grandfather (OR: 1.27, 95% CI: 1.14-1.41), siblings (OR: 4.18, 95% CI: 3.34-5.22) and children (OR: 5.47, 95% CI: 2.93-10.19) was associated with a significantly increased risk of developing diabetes. CONCLUSIONS: Family history and diabetes had a graded association in the Sri Lankan population, because the prevalence increased with the increasing number of generations affected. Family history of diabetes was also associated with the prevalence of obesity, metabolic syndrome and hypertension. Individuals with a family history of diabetes form an easily identifiable group who may benefit from targeted interventions.

Knowledge and perceptions about diet and physical activity among Sri Lankan adults with diabetes mellitus: a qualitative study.

BACKGROUND: Diabetes mellitus (DM) is a rapidly growing health concern in Sri Lanka. Diet and physical activity are important modifiable risk factors affecting the incidence, severity and management of DM. The present study aims to evaluate the knowledge and perceptions about dietary patterns and physical activity among a group of adults with DM in Sri Lanka using qualitative research methods. METHODS: Fifty adults from a cohort of diabetic patients attending the medical clinics at the National Hospital of Sri Lanka were invited for the study. Data were collected via 10 Focus Group Discussions. Verbatim recording and documenting emotional responses were conducted by two independent observers. Directed content analysis of qualitative data was done with the help of NVIVO v10.0. RESULTS: Mean age was 61.2 ± 9.9 years and 46 % were males. Mean duration of diabetes was 10.4 ± 7.5 years. All were aware of the importance of diet in the management of DM. But most had difficulty in incorporating this knowledge into their lives mostly due to social circumstances. The majority described a list of 'good foods' and 'bad foods' for DM. They believed that 'good' foods can be consumed at all times, irrespective of quantity and 'bad' foods should be completely avoided. Many believed that fruits were bad for diabetes, while vegetables were considered as a healthy food choice. The majority thought that there were 'special' foods that help to control blood glucose, the most common being curry leaves and bitter-gourd. Most study participants were aware of the importance of being physical active. However, there was lack of consensus and clarity with regards to type, duration, timing and frequency of physical activity. CONCLUSIONS: Despite understanding the importance of dietary control and physical activity in the management of diabetes, adherence to practices were poor, mainly due to lack of clarity of information provided. There were many myths with regards to diet, some of which have originated from health care professionals. More evidence is needed to support or refute the claims about 'special' foods that the participants believe as being good for diabetes.

High serum levels of reactive nitrogen species and low total antioxidant capacity in patients with resistant hypertension compared to those in age- gender matched healthy controls, controlled hypertension and follow up with propranolol treatment in the extended APPROPRIATE trial.

OBJECTIVES: To perform a comparative analysis of the extended APPROPRIATE trial of measures of reactive nitrogen species and antioxidant capacity in patients having resistant hypertension with controlled hypertension and healthy controls. RESULTS: Mean serum NO2- and NOx levels were significantly lower and mean AOC was significantly higher in patients with controlled hypertension (n = 38) and healthy controls (n = 38) compared to resistant hypertension (RHTN) patients (n = 40) at the pre-intervention stage (p < 0.001). The serum NO2-, NOx and AOC levels of both controlled hypertension and healthy controls were comparable to those of the RHTN patients following treatment with propranolol (n = 18). Considering all samples (n = 114) we noted that there were significant weak and moderate positive correlations between NO2- levels with systolic blood pressure (SBP) and diastolic blood pressure (DBP) (r = 0.396, p < 0.001 and r = 0.292, p = 0.004) as well as total NOx levels with SBP and DBP (r = 0.636 and r = 0.480 respectively, p < 0.001). Conversely, there was a significant negative correlation between AOC levels with SBP and DBP (r= -0.846 and r = -0.626 respectively, p < 0.001).

Efficacy and safety of 'true' cinnamon (Cinnamomum zeylanicum) as a pharmaceutical agent in diabetes: a systematic review and meta-analysis.

AIMS: Diabetes is a leading cause of morbidity and mortality worldwide. Studies have frequently looked at dietary components beneficial in treatment and prevention. We aim to systematically evaluate the literature on the safety and efficacy of Cinnamomum zeylanicum on diabetes. METHODS: A comprehensive search of the literature was conducted in the following databases; PubMed, Web of Science, Biological Abstracts, SciVerse Scopus, SciVerse ScienceDierect, CINAHL and The Cochrane Library. A meta-analysis of studies examining the effect of C. zeylanicum extracts on clinical and biochemical parameters was conducted. Data were analysed using RevMan v5.1.2. RESULTS: The literature search identified 16 studies on C. zeylanicum (five in-vitro, six in-vivo and five in-vivo/in-vitro). However, there were no human studies. In-vitro C. zeylanicum demonstrated a potential for reducing post-prandial intestinal glucose absorption by inhibiting pancreatic α-amylase and α-glucosidase, stimulating cellular glucose uptake by membrane translocation of glucose transporter-4, stimulating glucose metabolism and glycogen synthesis, inhibiting gluconeogenesis and stimulating insulin release and potentiating insulin receptor activity. The beneficial effects of C. zeylanicum in animals include attenuation of diabetes associated weight loss, reduction of fasting blood glucose, LDL and HbA(1c) , increasing HDL cholesterol and increasing circulating insulin levels. Cinnamomum zeylanicum also significantly improved metabolic derangements associated with insulin resistance. It also showed beneficial effects against diabetic neuropathy and nephropathy, with no significant toxic effects on liver and kidney and a significantly high therapeutic window. CONCLUSION: Cinnamomum zeylanicum demonstrates numerous beneficial effects both in vitro and in vivo as a potential therapeutic agent for diabetes. However, further randomized clinical trials are required to establish therapeutic safety and efficacy.

Glucocorticoid-induced adrenal insufficiency: an uncommon cause of hypercalcaemia.

Summary: Long-term use of exogenous glucocorticoids leads to the suppression of the hypothalamic-pituitary-adrenal axis. Therefore, if the glucocorticoid is withdrawn abruptly, patients will develop adrenal insufficiency. Hypercalcaemia is a rare but well-known complication of adrenal insufficiency. However, hypercalcaemia is a rare presentation of glucocorticoid-induced adrenal insufficiency (GI-AI). A 62-year-old patient with a past history of diabetes mellitus, ischaemic heart disease, stroke, hypertension and dyslipidaemia presented with polyuria, loss of appetite, malaise and vomiting for a duration of 2 months. His ionized calcium level was high at 1.47 mmol/L. Intact parathyroid hormone was suppressed (4.3 pg/mL) and vitamin D was in the insufficient range (24.6 ng/mL). Extensive evaluation for solid organ or haematological malignancy including contrast-enhanced CT chest, abdomen, pelvis, multiple myeloma workup and multiple tumour markers were negative. His synacthan-stimulated cortisol was undetectable thus confirming adrenal insufficiency. His adrenocorticotrophic hormone level was 3.82 pg/mL (4.7-48.8) excluding primary adrenal insufficiency. His MRI brain and other pituitary hormones were normal. Further inquiry revealed that the patient had taken over-the-counter dexamethasone on a regular basis for allergic rhinitis for more than 2 years and had stopped 2 weeks prior to the onset of symptoms. Therefore, a diagnosis of GI-AI leading to hypercalcemia was made. The patient was resuscitated with intravenous fluids and replacement doses of oral hydrocortisone were started with a plan of prolonged tailing off to allow the endogenous adrenal function to recover. His calcium normalized and he made a complete recovery. Learning points: Long-term use of glucocorticoids leads to the suppression of the hypothalamic-pituitary-adrenal axis. If the glucocorticoid is withdrawn abruptly, patients will develop adrenal insufficiency which is known as glucocorticoid-induced adrenal insufficiency. Adrenal insufficiency should be considered in the differential diagnosis of parathyroid hormone-independent hypercalcaemia. A thorough clinical history is of paramount importance in arriving at the correct diagnosis.

Effects of meditation on physiological and metabolic parameters in patients with type 2 diabetes mellitus "MindDM": study protocol for a randomized controlled trial.

BACKGROUND: Sri Lanka is faced with the challenge of managing a large population with diabetes mellitus by 2030. Psychological stress plays a major role in disease outcome by exerting physiological, psychological and social effects on individuals with chronic disorders. Meditation-based interventions have positive effects on the management of stress and diabetes, which are mediated via modulation of neuro-humoral mechanisms and autonomic functions, among others. Mechanisms of bio-physiological effects of meditation are considered to be through reduction of stress hormones, improvement of insulin resistance and improvement of autonomic dysfunction. METHODS: This study will be conducted as an open-label, randomized controlled clinical trial in the Faculty of Medicine, University of Colombo. The aim is to investigate the effects of meditation on glycaemic control and possible mechanisms of how meditation affects glycaemic control in patients with type 2 diabetes. The study was approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo (ERC/2019/094). Patients who are attending the professorial unit medical clinic with type 2 diabetes (172 in total) will be recruited based on inclusion-exclusion criteria. Patients who have never meditated or rarely meditated (less than once every three months) will be randomized using block randomization to meditation and waitlisted arms (1:1 allocation ratio). The meditation arm will undergo a mindfulness meditation program (selected after studying several meditation methods) conducted by a qualified instructor weekly for a period of 12 weeks in addition to usual care, while the waitlisted arm will only receive usual care. Daily meditation practices will be recorded in a diary. The primary outcome measure is HbA1c. Secondary outcome measures are fasting blood sugar, fructosamine, insulin resistance (calculated using fasting serum insulin), 24-h urinary cortisol, body mass index, cardiac autonomic reflex testing (Ewing's battery of tests) and orocecal transit time using hydrogen breath analysis. All these will be done prior to commencement of the intervention and after 3 months in both arms. Data will be analysed using SPSS V-23. DISCUSSION: This study aims to identify the effect of mindfulness meditation on glycaemic control and the possible mechanisms (neuro humoral and autonomic functions) by which beneficial effects are mediated. TRIAL REGISTRATION: Registered under Sri Lanka Clinical Trial Registry: SLCTR/2021/015 The Universal Trial Number (UTN) U1111-1266-8640.

Influence of Overweight and Obesity on Morbidity and Mortality among Hospitalized Patients in Sri Lanka: A Single-Center Analysis.

Background: Current evidence regarding the association between overweight and obesity and in-hospital morbidity and mortality is inconsistent and South Asian populations are underrepresented. Methods: Data relevant to anthropometry, hospital outcomes, complications, and medical diagnoses of all acute medical admissions to the National Hospital of Sri Lanka were collected over a period of 3 months. Analysis was performed with WHO international (ICs) and Asian obesity cut-offs (ACs). Results: Sample size was 2,128 (median age: 57 years [IQR: 42, 67], males: 49.7%). High prevalence of overweight (23.5%), generalized obesity (10.4%), central obesity (28.5%), and underweight (15.4%) was observed (ICs). Patients with either generalized or central obesity had significantly higher in-hospital mortality (4.8% versus 2.5%, p = 0.031) and acute kidney injury (AKI) (3.9% versus 1.2%) (p = 0.001) compared to normal weight. With ACs, overweight and obesity prevalence increased, without any significant increment in morbidity and mortality, but median length of hospital stay was significantly reduced in patients with generalized obesity compared to normal (3 [IQR: 2, 5] versus 4 [IQR: 2, 6], p = 0.014). Infections (44.4%) and cardiovascular diseases (CVDs) (25.9%) were the most common causes of admission. Overweight and generalized obesity or central obesity were associated with increased prevalence of acute CVDs and CVD risk factors and lower prevalence of acute infections, whilst underweight showed an inverse association. Conclusion: A double burden of malnutrition and diseases were noted among hospital admissions, with obesity being a risk factor for in-hospital all-cause mortality and AKI. Overweight and obesity were associated with increased CVDs and reduced infections. Larger prospective studies are required to characterize these associations among South Asians.

Derivation of anthropometric cut-off levels to define CVD risk in Sri Lankan adults.

Obesity is associated with increased cardiovascular risk. Anthropometric cut-off values derived for Caucasians may not be applicable to other populations. The main objective of the present study was to derive population-specific anthropometric cut-off values to define high CVD risk for Sri Lankan adults. A nationally representative sample of 4474 non-institutionalised adults aged ≥ 18 years was analysed. Cut-off values to provide optimum sensitivity and specificity were derived using receiver-operating characteristic curve analysis. BMI, waist circumference (WC), waist-to-hip ratio (WHR), blood pressure and overnight fasting venous blood samples were collected to measure glucose, HDL-cholesterol and TAG. An oral glucose tolerance test was also performed. The results suggested that the age-adjusted BMI, WC and WHR were significantly associated with all cardiovascular risk factors (P < 0·001). Cut-off values for BMI, WC and WHR for males were 20·7 kg/m2, 76·5 cm and 0·89, respectively. The respective values for females were 22·0 kg/m2, 76·3 cm and 0·85. The common cut-off value for BMI for males and females was 21·5 kg/m2. Similarly, WC and WHR cut-off values for both males and females were 76·3 cm and 0·87, respectively. The Asian and Caucasian anthropometric cut-off levels showed lower sensitivity and higher false negative percentage compared with newly derived cut-off levels. In conclusion, BMI, WC and WHR were all associated with increased CVD risk. We propose the following anthropometric cut-off points to determine high CVD risk level for Sri Lankan adults: BMI ≥ 21·5 kg/m2, WC ≥ 76 cm and WHR ≥ 0·85 (women) and 0·90 (men).

Relative validity of a brief dietary survey to assess food intake and adherence to national dietary guidelines among Sri Lankan adults.

BACKGROUND: Suboptimal diet is the leading cause of global morbidity and mortality. Addressing this problem requires context-specific solutions informed by context-specific data collected by context-specific tools. This study aimed to assess the relative validity of a newly developed brief dietary survey to estimate food intake and adherence to the Food Based Dietary Guidelines for Sri Lankans. METHODS: Between December 2018 and February 2019, we interviewed 94 Sri Lankan adults living in Colombo (Western Province), Kalutara (Western Province), and Trincomalee (Eastern Province). We assessed the relative validity of the Sri Lankan Brief Dietary Survey (SLBDS) with Wilcoxon rank-sum tests, Spearman's Rho correlation coefficients, Bland-Altman plots, and Cohen's kappa tests using a 24-h Dietary Recall (24DR) as reference. RESULTS: Ninety-four adults (40.7 years ±12.6; 66% female) completed both surveys during the same interview. With the exception of 'Fish, pulses, meat and eggs' food group median intake, which was underestimated by the SLBDS compared to the 24DR, there was no strong evidence of difference between median intakes reported by the two methods. Correlation coefficients were highest for 'Milk and dairy products' (0.84) at the food group level and for 'dosa', 'hoppers', 'milk rice', and 'dried fish' (1.00) among individual food and beverages. Visual exploration of Bland-Altman plots showed acceptable agreement between the SLBDS and 24DR, with the SLBDS tending to overestimate consumption as the number of servings of 'Rice, bread, other cereals and yams' and 'Vegetables' consumed increased and slightly underestimate consumption as the number of servings of 'Fish, pulses, meat and eggs', 'Milk and dairy products', and 'Nuts' increased. Kappa values ranged from from 0.59 (95% CI: 0.32-0.86) for 'Vegetables' to 0.81 (95% CI: 0.66-0.96) for 'Fruit' indicating a moderate to strong level of agreement. CONCLUSIONS: Having been developed for and relatively validated with the study population in question, our study shows that the SLBDS can be used as a fit for purpose research tool. Additional research is needed to assess SLBDS test-retest reliability and to validate further the reporting of salt, oil, and coconut intake.

The impact of propranolol on nitric oxide and total antioxidant capacity in patients with resistant hypertension-evidence from the APPROPRIATE trial.

OBJECTIVES: The objective was to assess the effect of propranolol on oxidative stress and anti-oxidant potential in patients with resistant hypertension as a secondary analysis of the APPROPRIATE trial. This randomized double blinded clinical trial recruited patients with resistant hypertension and allocated forty patients to propranolol and placebo in 1:1 ratio. The pro-oxidant state (nitrate and nitrite) was assessed using modified Griess assay. The total anti-oxidant capacity was measured using ABTS assay. RESULTS: Analysis was performed for 18 patients from the propranolol group and 15 from the placebo group. A decline in end point ambulatory blood pressure (p = 0.031) and greater mean reduction in office SBP (29.7 ± 13.0 mmHg, p = 0.021) was noted in the propranolol arm. Nitrate and nitrite levels were lower at the end of a 90 day follow up period in both arms, with a greater mean reduction with propranolol. A significant increase in the AOC was noted in both arms with higher incremental value with Propranolol. The findings of this study do not demonstrate a statistically significant effect of propranolol on the oxidative stress/antioxidant balance in patients with resistant hypertension. The observed trends merit further evaluation.

Evaluation of the accuracy and precision of glucometers currently used in Sri Lanka.

AIMS: Life threatening macrovascular and microvascular complications of diabetes can be minimized by effective glycaemic control. Self monitoring of blood glucose with glucometers is recognized as a cost effective strategy to improve glycaemic control. However accuracy and precision of glucometers will determine the effectiveness of this strategy. We aimed to evaluate accuracy and precision of commonly used glucometers in Sri Lanka. MATERIALS AND METHODS: An observational study was conducted in a tertiary care setting including patients with diabetes and healthy volunteers. Eight commonly used glucometers were used. Blood glucose was measured in 50 participants (16 healthy volunteers, 34 patients with diabetes) in finger prick capillary blood using glucometers and venous blood using standard laboratory methods, and were compared to determine accuracy. Repeated measurements from same glucometer with a single finger prick were made and compared to determine precision. RESULTS: Only one glucometer showed insignificant difference to venous plasma glucose values. Only one glucometer met ADA recommended bias of <5%. None of the glucometers fell within the ISO recommendations for accuracy. CONCLUSION: Majority of commonly used glucometers in Sri Lanka do not meet the ADA recommendations and ISO standards for accuracy and precision. However their variations are unlikely to make significant adverse impact on patient management.

Prevalence and clinical characteristics of maternally inherited diabetes and deafness caused by the mt3243A > G mutation in young adult diabetic subjects in Sri Lanka.

AIMS: The maternally inherited mt3243A > G mutation is associated with a variable clinical phenotype including diabetes and deafness (MIDD). We aimed to determine the prevalence and clinical characteristics of MIDD in a large South Asian cohort of young adult-onset diabetic patients from Sri Lanka. METHODS: DNA was available from 994 subjects (age of diagnosis 16-40 years, age at recruitment < or = 45 years). Mutation screening was performed using a QRT-PCR method on an ABI 7900HT system using sequence-specific probes. Samples with heteroplasm > or = 5.0% were considered positive. RESULTS: Nine (four males) mutation-positive subjects were identified (prevalence 0.9%). They were diagnosed at a younger age (25.9 +/- 4.8 years vs. 31.9 +/- 5.6 years, P = 0.002) and were lean (body mass index [BMI] 18.7 +/- 2.7 kg/m(2) vs. 24.7 +/- 4.0 kg/m(2), P < 0.001) compared to NMCs. One mutation-positive subject (11.1%) had metabolic syndrome, compared to 633 (64.3%) of NMCs. Insulin therapy within 6 months of diagnosis was used in four (44.0%) carriers compared to 6.9% of NMCs (P = 0.002). Combined screening criteria of any two of maternal history of diabetes, personal history of hearing impairment and family history of hearing impairment only identified five (55%) of the carriers, with a positive predictive value of 7.4%. CONCLUSIONS: The prevalence of mt3243A > G mutation among young adult-onset diabetic subjects from Sri Lanka was 0.9%. Our study demonstrates that a maternal family history of diabetes and either a personal and/or family history of deafness only distinguish half of patients with MIDD from Sri Lankan subjects with young-onset diabetes.

Prevalence and projections of diabetes and pre-diabetes in adults in Sri Lanka--Sri Lanka Diabetes, Cardiovascular Study (SLDCS).

AIMS: To determine the prevalence of diabetes mellitus and pre-diabetes (impaired fasting glucose and impaired glucose tolerance) in adults in Sri Lanka. Projections for the year 2030 and factors associated with diabetes and pre-diabetes are also presented. METHODS: This cross-sectional study was conducted between 2005 and 2006. A nationally representative sample of 5000 adults aged >or= 18 years was selected by a multi-stage random cluster sampling technique. Fasting plasma glucose was tested in all participants and a 75-g oral glucose tolerance test was performed in non-diabetic subjects. Prevalence was estimated for those > 20 years of age. RESULTS: Response rate was 91% (n = 4532), males 40%, age 46.1 +/- 15.1 years (mean +/- standard deviation). The age-sex standardized prevalence (95% confidence interval) of diabetes for Sri Lankans aged >or= 20 years was 10.3% (9.4-11.2%) [males 9.8% (8.4-11.2%), females 10.9% (9.7-12.1%), P = 0.129). Thirty-six per cent (31.9-40.1%) of all diabetic subjects were previously undiagnosed. Diabetes prevalence was higher in the urban population compared with rural [16.4% (13.8-19.0%) vs. 8.7% (7.8-9.6%); P < 0.001]. The prevalence of overall, urban and rural pre-diabetes was 11.5% (10.5-12.5%), 13.6% (11.2-16.0%) and 11.0% (10.0-12.0%), respectively. Overall, 21.8% (20.5-23.1%) had some form of dysglycaemia. The projected diabetes prevalence for the year 2030 is 13.9%. Those with diabetes and pre-diabetes compared with normal glucose tolerance were older, physically inactive, frequently lived in urban areas and had a family history of diabetes. They had higher body mass index, waist circumference, waist-hip ratio, systolic/diastolic blood pressure, low-density lipoprotein cholesterol and triglycerides. Insulin was prescribed to 4.4% (2.7-6.1%) of all diabetic subjects. CONCLUSIONS: One in five adults in Sri Lanka has either diabetes or pre-diabetes and one-third of those with diabetes are undiagnosed.

Translation and Validation of the Sinhalese Version of the Brief Medication Questionnaire in Patients with Diabetes Mellitus.

BACKGROUND: Adherence to long-term therapy for diabetes remains low. Accurately measuring adherence is the primary step in improving adherence. We translated and validated the Sinhalese version of the Brief Medication Questionnaire (BMQ) in patients with diabetes. METHODS: The study was conducted at the National Hospital of Sri Lanka between April and December 2017, including 165 patients with diabetes. BMQ was translated into Sinhalese using the translation-back translation method. The translated questionnaire validation included evaluation of internal consistency, temporal stability, and performance in regard to a gold standard (HbA1c). RESULTS: Mean age (±SD) was 60.6 ± 11.1 years, and 46.1% were males. Mean duration of diabetes in the participants was 13.4 ± 7.8 years. Mean HbA1c was 8.3 ± 1.7%, with poor glycaemic control (HbA1c ≥ 8.5%) identified in 41.8%. Medication adherence measured by the BMQ regimen, belief, and recall screens were 39.4%, 75.8%, and 18.8%, respectively. In the analysis of temporal stability, the overall BMQ and the regimen, belief, and recall screens demonstrated good concordance between test and retest with significant gamma correlation coefficients of r = 0.85 (p < 0.001), r = 0.81 (p < 0.001), r = 0.84 (p < 0.001), and r = 0.91 (p < 0.001), respectively. The overall BMQ had a Cronbach α coefficient of 0.65 (95% CI: 0.61-0.70). The questionnaire performance with regards to the gold standards for the overall BMQ AUC was 0.73 (95% CI 0.65-0.80), while the BMQ regimen screen AUC was 0.61 (95% CI 0.53-0.70). The overall BMQ score with a cutoff value of 2 presented better equilibrium between sensitivity and specificity for the gold standard. Those with low adherence had a significantly higher percentage of poor glycaemic control (HbA1c ≥ 8.5%). CONCLUSION: The translated questionnaire demonstrated good reliability (internal consistency), temporal stability (test-retest reliability), and validity when assessed using a gold standard for disease control. Using culturally validated tools to evaluate adherence may help clinicians to identify low adherence and institute corrective measures.