A randomised crossover trial: Exploring the dose-response effect of carbohydrate restriction on glycaemia in people with well-controlled type 2 diabetes.

BACKGROUND: Trials investigating the role of carbohydrate restriction in the management of glycaemia in type 2 diabetes (T2D) have been confounded by multiple factors, including degree of calorie restriction and dietary protein content, as well as by no clear definition of a low-carbohydrate diet. The present study aimed to provide insight into the relationship between carbohydrate restriction and glycaemia by testing the effect of varying doses of carbohydrate on continuous glucose concentrations within a range of intakes defined as low-carbohydrate at the same time as controlling for confounding factors. METHODS: This was a randomised crossover trial in participants with T2D (HbA1c: 6.6 ± 0.6%, 49 ± 0.9 mmol mol-1 ) testing five different 6-day eucaloric dietary treatments with varying carbohydrate content (10%, 15%, 20%, 25%, and 30% kcal). Diets exchanged %kcal from carbohydrate with fat, keeping protein constant at 15% kcal. Daily self-weighing was employed to ensure weight stability throughout each treatment arm. Between dietary treatments, participants underwent a washout period of at least 7 days and were advised to maintain their habitual diet. Glycaemic control was assessed using a continuous glucose monitoring device. RESULTS: Twelve participants completed the study. There were no differences in 24-h and post-prandial sensor glucose concentrations between the 30 and 10%kcal doses (7.4 ± 1.1 mmol L-1 vs. 7.6 ± 1.3 mmol L-1 [p = 0.28] and 8.1 ± 1.5 mmol L-1 vs. 8.5 ± 1.4 mmol L-1 [p = 0.28], respectively). In our exploratory analyses, we did not find any dose-response relationship between carbohydrate intake and glycaemia. A small amount of weight loss occurred in each treatment arm (range: 0.4-1.1 kg over the 6 days) but adjusting for these differences did not influence the primary or secondary outcomes. CONCLUSIONS: Modest changes in dietary carbohydrate content in the absence of weight loss at the same time as keeping dietary protein intake constant do not appear to influence glucose concentrations in people with well-controlled T2D. SUMMARY: This study randomised people with T2D to receive five different doses of carbohydrate from 10% to 30% of calories in random order to see what effect it had on their blood glucose.

Diabetes and TelecommunicationS (DATES) study to support self-management for people with type 2 diabetes: a randomized controlled trial.

BACKGROUND: The increasing prevalence of type 2 diabetes and suboptimal glycaemic control in Kuwait requires novel, wide-reaching, low-cost interventions to motivate and mobilise individuals towards more effective self-management. More than 2 million people in Kuwait own mobile phones. We will test whether automated personalised health text messages based on principles of motivational interviewing and are responsive to biodata delivered remotely is potentially effective in improving glycaemic control compared to usual care. METHODS: This is a two-arm parallel single-blind randomised controlled trial of 572 individuals with type 2 diabetes in Kuwait. We will develop a culturally appropriate database of text messages supporting positive lifestyle changes in type 2 diabetes. A computer programme will deliver over 400 text messages over a 12-month period using algorithms which provide participants with information on diet and physical activity as well as personalised messages regarding motivators to change behaviours. Individuals aged 18-75 years with established type 2 diabetes who are fluent in Arabic or English and officially resident in Kuwait will be identified via screening of hospital diabetes clinic and primary care practices and invited to participate. A sample of 572 participants will be randomised to usual care or usual care plus the DATES text message intervention. Randomisation will be conducted by an independent Clinical Trials Unit and researchers collecting baseline and outcome data will be blinded to treatment allocation. The primary outcome is change in HbA1c and weight at 12 months in both study arms. Secondary outcomes will include changes in physical activity, fasting lipids and quality of life in both study arms. DISCUSSION: The potential of mobile phones in improving diabetes self-care in settings with a high prevalence of diabetes and widespread mobile phone usage has face validity. Mobile phones and text messaging are an understudied virtual communication media which can deliver discrete focused psychological support to motivate and enable diabetes self-care changes. TRIAL REGISTRATION: ISRCTN10342151 . 11/03/2015.

Seasonal differences in physical activity, sedentary behaviour, and sleep patterns in people with type 1 diabetes in Kuwait.

AIMS: The main aim of the current study was to measure physical activity, sedentary behaviors and sleep levels across the different seasons in people with type 1 diabetes in Kuwait. METHODS: A prospective cross-sectional study was conducted from August 2021 to September 2022. Physical activity and sleep metrics were measured over a 7-day period with a wrist-worn accelerometer (GENEActiv). Overall physical activity was measured as a Euclidean Norm Minus One in milli gravitational units (mg). Accelerometer metrics were compared across the seasons and between the sex. RESULTS: A total of 784 people with type 1 diabetes participated. Mean daily physical activity was 25.2 mg (SD = 7.3). Seasonal differences were seen in overall physical activity (p = 0.05), inactivity (p = 0.04), light activity (p = 0.001), the intensity gradient (p = 0.001) and sleep efficiency (p = 0.02). Poorer metrics were generally seen in Spring and Summer. Overall physical activity, moderate and vigorous physical activity, and inactivity were significantly higher in males compared to females (p ≤ 0.02). Females had a longer sleeping duration (p = 0.02), and higher sleep efficiency (p = 0.04) and light physical activity (p = 0.01). Overall physical activity and the intensity gradient were negatively associated with HbA1c (both p = 0.01). CONCLUSIONS: Physical activity levels were generally low and sleep poor in people with type 1 diabetes in Kuwait and these varied by sex and season. The current data are useful to target and develop interventions to improve physical activity and glycemic control.

Obesity Treatments to Improve Type 1 Diabetes (OTID): a randomized controlled trial of the combination of glucagon-like peptide 1 analogues and sodium-glucose cotransporter 2 inhibitors-protocol for Obesity Treatments to Improve Type 1 Diabetes (the OTID trial).

BACKGROUND: The guidelines of the American Diabetes Association and European Association for the Study of Diabetes suggest that patients with obesity type 2 diabetics and chronic kidney disease need either glucagon-like peptide 1 receptor analogues or sodium-glucose cotransporter-2 inhibitors. If neither achieve metabolic control, then the recommendation is to combine both drugs. The evidence base for combining glucagon-like peptide 1 receptor analogues and sodium-glucose cotransporter-2 inhibitors is not well researched, and hence, the impact of the guidelines is limited. The aim of this randomized controlled trial is to test the impact of the combination of glucagon-like peptide 1 receptor analogues/sodium-glucose cotransporter-2 inhibitors on body weight and kidney damage, in patients with type 1 diabetes and chronic kidney disease. In addition, we will explore the associated changes in the metabolic pathways with each of the treatments used in this randomized controlled trial. METHODS: In this 6-month randomized control trial, 60 participants aged between 21 and 65 years, with a body mass index above 25 kg/m2, and type 1 diabetics with chronic kidney disease will be randomized to receive 1 of 5 possible treatments: (1) standard care (control), (2) glucagon-like peptide 1 receptor analogues alone, (3) sodium-glucose cotransporter-2 inhibitors alone, (4) combination of glucagon-like peptide 1 receptor analogues and sodium-glucose cotransporter-2 inhibitors and (5) combination of glucagonlike peptide 1 receptor analogues and sodium-glucose cotransporter-2 inhibitors with intensive lifestyle advice. The primary objective will be the percentage change in total body weight from baseline at 6 months. The secondary objectives are to compare the change in glycaemia; blood pressure; dyslipidaemia; albuminuria; proportion of participants reaching weight loss of ≥ 5%, ≥ 10% and ≥ 15%; and change in BMI (kg/m2) from baseline and change in waist circumference (cm). All the experiments will be conducted at the Dasman Diabetes Institute after approval from the local research and ethics committee. DISCUSSION: The present randomized controlled trial aims to investigate the impact of the combination of glucagon-like peptide 1 receptor analogues and sodium-glucose cotransporter-2 inhibitors on body weight and kidney damage in patients with type 1 diabetes mellitus and chronic kidney disease, as well as exploring the associated changes in the metabolic pathways with each of the treatments used. This study addresses the current gap in the evidence base regarding the combination of these two drugs, which is particularly relevant given the American Diabetes Association and European Association for the Study of Diabetes guidelines recommending their combined use for patients with obesity, type 2 diabetes, and chronic kidney disease who do not achieve metabolic control with either drug alone. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05390307 Trial registration date - 25th May 2022.

Association Between Depression, Diabetes Self-Care Activity and Glycemic Control in an Arab Population with Type 2 Diabetes.

Purpose: Poor self-care behavior and depression are associated with worse glycemic control, but the relationship between these variables is poorly reported. The present study aimed to describe self-care behaviors and explore the association between depression, self-care and glycemic control in people with type 2 diabetes in an Arab population. Patients and Methods: This study recruited 446 patients with type-2 diabetes from an outpatient clinic in Kuwait and completed assessments of diabetes self-care using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire and depression using the Patients Health Questionnaire-9 (PHQ-9) scales. Multiple linear regression models were used to determine the associations between depression, self-care behaviors and glycemic control. Results: Self-care behaviors were highest for medication taking (92.9%), an average for foot care (61.4%), blood glucose testing (60%) and healthy diet (55.7%), and lowest for exercise (27.1%). Depression, poor self-care activities and poor HbA1c levels were inter-correlated in univariate analysis (p< 0.03). In regression analysis, following healthful eating (B= -0.27, p< 0.001), general eating plan (B= -0.21, p= 0.01), more space carbohydrates evenly throughout the day (B= - 0.17, p= 0.03) and exercise at least 30 minutes (B= -0.17, p= 0.02) behaviors were associated with better HbA1c levels. However, depression was associated with poor scores of following a general eating plan (B= -0.20, p= 0.03), space carbohydrates evenly throughout the day (B= -0.21, p= 0.05), and exercising at least 30 minutes (B= -0.24, p= 0.03) behaviors. Depression scores were also associated with poor HbA1c levels (B= 0.32, p= 0.03). However, this association no longer persists after mutual adjustment with following a healthy diet (B= 0.14, p= 0.38) and exercise (B = 0.26, p = 0.08) behaviors. Conclusion: Self-care activity was less than fifty percent in people with type 2 diabetes and higher activity was associated with better glycemic control. However, depression adversely affects self-care behaviors. To maintain and achieve glycemic control, diabetes educators might motivate people with type 2 diabetes to enhance their self-care activities, particularly those with depression symptoms and poor compliance with self-care activities.

Effect of COVID-19 vaccine on blood glucose metrics in Arabic people with type 1 diabetes.

Introduction: People with diabetes are at a higher risk for coronavirus disease-19 (COVID-19) and hence are prioritized for vaccination. The aim of the current study was to investigate the effects of COVID-19 vaccination on blood glucose control in Arabic people with type 1 diabetes (T1D). Secondary aim was to compare the responses between the two vaccines approved for use in Kuwait. Method: This retrospective study compared ambulatory glucose metrics, using a continuous glucose monitoring device, measured for 14 days before, and 7 days and 14 days after, the first and second dose of the COVID-19 vaccine in Arabic people with Type 1 diabetes (T1D). We also explored possible links with vaccine type and other clinical characteristics. Glucose metrics calculated were time in range (TIR, 3.9-10 mmol/L), time above range (TAR, 10.1- 13.9 mmol/L or >13.9 mmol/L), time below range (TBR, 3- 3.9 mmol/L or <3 mmol/L) and glucose variability (CV). Results: We enrolled 223 participants in the study. Over the 7 days period after the first vaccination dose there was a decrease in TIR (mean difference (SD) -1.9% ± 14.8%; p = 0.05) and increase in TAR >10 mmol/L (2.2% ± 15.9%; p = 0.04), with no effects on TBR. These effects were not seen after the second dose or 14 days after either dose. There was a decrease in CV over the 7 days period after the first (-1.2% ± 7.4%; p = 0.02) and second vaccine doses (-1.1% ± 6.9%; p = 0.03), with no effects noted 14 days after either dose. In subgroup analysis similar effects on TIR and TAR were also seen in those who had received the viral vector-based vaccine, but not the mRNA-based vaccine, although the decrease in CV was seen in those who had received the mRNA based vaccine but not the viral vector-based vaccine. Conclusion: We found a temporary impairment in glucose control in the first 7 days, particularly among individuals receiving viral vector vaccines. The group receiving mRNA vaccine was likely to experience an increase in glucose levels above the target range. However, the temporary change in metrics appears to return to pre-vaccination levels after one-week post-vaccination. The effects on glycemic parameters were more neutral after the second dose.

Glucagon-like peptide-1 agonists combined with sodium-glucose cotransporter-2 inhibitors reduce weight in type 1 diabetes.

OBJECTIVE: This study evaluated whether adding sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide-1 receptor agonists (GLP1-RA) to insulin reduced weight and glycemia in people with type 1 diabetes. METHODS: This retrospective analysis of electronic health records evaluated 296 people with type 1 diabetes over 12 months after medications were first prescribed. Four groups were defined: control n = 80, SGLT2i n = 94, GLP1-RA n = 82, and combination of drugs (Combo) n = 40. We measured changes at 1 year in weight and glycated hemoglobin (HbA1c). RESULTS: The control group did not have changes in weight or glycemic control. The mean (SD) percentage weight loss after 12 months was 4.4% (6.0%), 8.2%  (8.5%), and 9.0% (8.4%) in the SGLT2i, GLP1-RA, and Combo groups, respectively (p < 0.001). The Combo group lost the most weight (p < 0.001). The HbA1c reduction was 0.4% (0.7%), 0.3% (0.7%), and 0.6% (0.8%) in the SGLT2i, GLP1-RA, and Combo groups, respectively (p < 0.001). The Combo group had the biggest improvements in glycemic control and total and low-density lipoprotein cholesterol compared with baseline (all p < 0.01). Severe adverse events were similar between all the groups, with no increased risk of diabetic ketoacidosis. CONCLUSIONS: The SGLT2i and GLP1-RA agents on their own improved body weight and glycemia, but combining the medications resulted in more weight loss. Treatment intensification appears to result in benefits with no difference in severe adverse events.

Prevalence and risk factors for diabetic peripheral neuropathy, neuropathic pain and foot ulceration in the Arabian Gulf region.

AIMS/INTRODUCTION: This study determined the prevalence and risk factors for diabetic peripheral neuropathy (DPN), painful DPN and diabetic foot ulceration (DFU) in patients with type 2 diabetes in secondary healthcare in Qatar, Kuwait and the Kingdom of Saudi Arabia. MATERIALS AND METHODS: Adults aged 18-85 years with type 2 diabetes were randomly enrolled from secondary healthcare, and underwent clinical and metabolic assessment. DPN was evaluated using vibration perception threshold and neuropathic symptoms and painful Diabetic Peripheral Neuropathy was evaluated using the Douleur Neuropathique 4 questionnaire. RESULTS: A total of 3,021 individuals were recruited between June 2017 and May 2019. The prevalence of DPN was 33.3%, of whom 52.2% were at risk of DFU and 53.6% were undiagnosed. The prevalence of painful DPN was 43.3%, of whom 54.3% were undiagnosed. DFU was present in 2.9%. The adjusted odds ratios for DPN and painful DPN were higher with increasing diabetes duration, obesity, poor glycemic control and hyperlipidemia, and lower with greater physical activity. The adjusted odds ratio for DFU was higher with the presence of DPN, severe loss of vibration perception, hypertension and vitamin D deficiency. CONCLUSIONS: This is the largest study to date from the Middle East showing a high prevalence of undiagnosed DPN, painful DPN and those at risk of DFU in patients with type 2 diabetes, and identifies their respective risk factors.

The Epidemiology of Depression and Diabetes Distress in Type 2 Diabetes in Kuwait.

This study is aimed at describing the prevalence of and risk factors for depression and diabetes distress in people with type 2 diabetes and whether depression and distress are independently associated with worse biomedical outcomes. The study was of cross-sectional design. The setting was the Dasman Diabetes Institute, Kuwait. The Patient Health Questionnaire-9 (PHQ-9) was used to measure the prevalence of depression, defined as a score ≥ 10 (depression caseness). The Problem Areas in Diabetes (PAID) was used to measure diabetes-related distress. Data on biomedical outcomes, lifestyle factors, and sociodemographic information were collected. The prevalence of depression and diabetes distress caseness was 29% and 14%, respectively. Depression caseness patients were more likely to be female (60%; p = 0.001), have Kuwaiti nationality (68%, p = 0.121), were on insulin (67%, p = 0.001), have higher body mass index (p = 0.047), were less physically active (78%; p = 0.034), have a higher PAID score (p < 0.001), and have hypertension (74%, p = 0.047). After adjustment of sociodemographics (age, gender, and marital status) and body mass index, the prevalence of depression was associated with higher HbA1c (B = 0.04, 95% confidence interval 0.01 to 0.60), while diabetes distress had a weak association with HbA1c (B = 0.13, 95% confidence interval 0.04 to 0.22). In conclusion, people with type 2 diabetes in Kuwait have a high prevalence of depression but lower diabetes distress and this was associated with worse glycaemic control.

Continuous Glucose Monitoring of Glycemic Variability During Fasting Post-Sleeve Gastrectomy.

INTRODUCTION: Day-long fasting creates considerable metabolic stress that poses challenges in people with diabetes and those who have undergone bariatric surgery. Clinical knowledge of glucose fluctuations and the risks for such patients during fasting is limited. OBJECTIVES: This study examined the effect of intermittent fasting on glucose excursions, hypoglycemia, and hyperglycemia in people with or without diabetes who had sleeve gastrectomy compared with healthy individuals. METHODS: This open-label, prospective study compared interstitial glucose profiles measured with continuous glucose monitoring system for 72 h during fasting and non-fasting periods between four groups comprising 15 participants each: people with obesity and medicine-treated type 2 diabetes (T2D) only, obesity and T2D treated with sleeve gastrectomy, obesity without T2D treated with sleeve gastrectomy, and healthy, normal-weight non-diabetic controls. RESULTS: The mean 72-h glucose concentration was significantly lower during the fasting period for all groups (p ≤ 0.041), with the highest glucose concentrations in the medicine-treated T2D-only group and the lowest concentrations in the sleeve gastrectomy in non-T2D group. The mean glucose profiles of all the groups showed a marked increase in interstitial glucose on breaking the fast, which was exaggerated in the two diabetes groups. The mean amplitude of glycemic excursions did not differ significantly within each group between fasting and non-fasting. No significant difference was noted in the fraction of time in the hypoglycemic range between the fasting and non-fasting periods in any group. CONCLUSION: Intermittent fasting had no adverse effect on glycemic control in people with or without diabetes who had undergone sleeve gastrectomy.

Correction to: Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength.

An amendment to this paper has been published and can be accessed via the original article.

Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength.

BACKGROUND: Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes. However, studies, so far, have employed supervised resistance exercise in a laboratory or gym facility which limits the future translation of such exercise in to clinical practice and recommendations. Our primary aim, therefore, is to test the hypothesis, in a randomized controlled trial, that home-based resistance exercise training and gym-based resistance exercise training both reduce HbA1c levels in people with type 2 diabetes compared to control. We will also investigate the effects of home- and gym-based resistance exercise training on muscle strength and body composition. METHODS: The current study is a three-arm randomised controlled trial which will be conducted with 150 eligible people with type 2 diabetes to compare home-and gym-based resistance exercise training with usual care in Kuwait. The interventions will be delivered by exercise specialists and last for 32 weeks. The primary outcomes are HbA1c with secondary outcomes measuring muscle function, body composition, physical activity and quality of life. DISCUSSION: Ethical approval has been granted by the Dasman Diabetes Institute ethical review committee (RA/197/2019). Study findings will be disseminated through presentation at scientific conferences and in scientific journals. TRIAL REGISTRATION: NCT04136730: Retrospectively registered on 21 October 2019.

A prospective study of the effect of fasting during the month of Ramadan on depression and diabetes distress in people with type 2 diabetes.

AIMS: Depression in diabetes has been associated with hyperglycemia and an increase risk for metabolic disorder complications. Ramadan is a period of self-discipline, self control, and spirituality, which has shown benefits in physical, mental, and social well being. The aim of this study is to examine the association between fasting during the month of Ramadan and depression. METHODS: Data from 463 participants were collected at three time points. A paired t-test was used to examine the difference between PHQ-9 score and difference of PAID score before and after Ramadan to measure depression. A multivariable regression with adjusting for potential confounders was used to study the association between fasting and depression. RESULTS: The difference in PHQ-9 score before and after Ramadan was -3.5 points (95% Confidence Interval (CI) -4.05 to -2.95). The difference in PAID score before and after the Ramadan was -5.02 points (95% CI -6.38 to -3.69). For every one year increase in diabetes diagnosis PHQ-9 score decreased by 0.09 (95% CI -0.17 to 0.003) after Ramadan. Female participants had 1.17 more points (95% CI -0.23 to 0.02) decrease in PHQ-9 score compared to male participants. CONCLUSION: Improving depression in people with diabetes is crucial in controlling blood glucose and metabolic disorder complications in people with diabetes. People with diabetes who experience depression may improve their depression by increasing self discipline, self control, and manage disease.

Photo-Assisted Dietary Method Improves Estimates of Dietary Intake Among People with Sleeve Gastrectomy.

INTRODUCTION: Bariatric operations are effective obesity treatments because of the significant reductions in food intake after surgery, but weight regain remains a problem in a small group of patients after surgery. Estimating food intake is difficult due to dieting status, weight, gender, and challenges with estimating portion size. We aimed to evaluate the use of digital food photography in comparison to conventional methods among patients after sleeve gastrectomy. METHODS: Participants used a mobile device (mHealth) to photo-document their dietary intake of all food and beverages consumed before and after eating. They also completed a 24 h food recall interview with a dietician. RESULTS: Data from 383 eating occasions were analyzed. Food intake using 24 h recall was reported as 972.5 ± 77 kcal and estimates from photographs were 802.9 ± 63.4 kcal, with a difference of 169.6 ± 451.4 kcal (95% confidence interval (CI) of 41.4 to 297.9 kcal, p = 0.005). There was no difference for protein intake, but carbohydrate intake reported during the 24 h recall was 541.2 ± 298 kcal and estimates from photographs were 395.2 ± 219.6 kcal, with a difference of 145.8 ± 256.3 kcal (95% CI of 73.2 to 218.8 kcal, p = 0.0001). CONCLUSION: After sleeve gastrectomy, patients reported eating more total calories and calories from carbohydrates compared to estimations using photographs. The implication for patients are that tools such as mHealth might be useful to optimize food intake and calories after sleeve gastrectomy, especially for those patients that may struggle with weight regain after surgery.