Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort

Abstract

ObjectivesDiabetes Intervention Accentuating Diet and Enhancing Metabolism-I (DIADEM-I) is the first randomised controlled trial (RCT) in the Middle East and North Africa (MENA) region testing the effectiveness of an intensive lifestyle intervention (ILI) for weight loss and diabetes remission. We report on the recruitment process and baseline characteristics of the DIADEM-I cohort based on origin (Middle East vs North Africa), and waist circumference.DesignDIADEM-I is an open-label randomised, controlled, parallel group RCT recruiting young individuals (18–50 years) with early type 2 diabetes (≤3 years since diagnosis) originating from MENA. Individuals from primary care were randomised to usual medical care or ILI (total dietary replacement phase using meal replacement products, followed by staged food reintroduction and physical activity support). The primary outcome is weight loss at 12 months. Other outcomes are glycaemic control and diabetes remission.SettingPrimary care, Qatar.Participants147 (73% men) randomised within DIADEM-I who were included in the final trial data analysis.Outcome measuresRecruitment metrics, and baseline clinical and metabolic characteristics.ResultsOf 1498 people prescreened, 267 (18%) were invited for screening and 209 (78%) consented. 173 (83%) were eligible. 15 (7%) withdrew before randomisation and the remaining 158 were randomised. Mean age was 42.1 (SD 5.6) years and mean body mass index was: 36.3 (5.5) kg/m2 (women) and 34.4 (5.4) kg/m2 (men). Mean diabetes duration was 1.8 (1.0) years and mean glycosylated haemoglobin (HbA1c) was 7.0% (1.30) (52.5 mmol/mol (SD 14.3)). Participants originated from 13 countries. Those from North Africa reported greater physical activity and had lower family history of diabetes. 90% of subjects were taking diabetes medications and 31% antihypertensives. Those with greater waist circumference had significantly higher insulin resistance and lower quality of life.ConclusionRecruitment of participants originating from the MENA region into the RCT was successful, and study participation was readily accepted. While DIADEM-I participants originated from 13 countries, there were few baseline differences amongst participants from Middle East versus North Africa, supporting generalisability of RCT results.Trial registration numberISRCTN20754766; NCT03225339

Effects of Diet, Lifestyle, Chrononutrition and Alternative Dietary Interventions on Postprandial Glycemia and Insulin Resistance

“…A more recent meta-analysis of 28 RCTs showed that lifestyle interventions were more effective than the standard care regarding the glycemic control of subjects with T2DM, particularly when there was weight loss [29]. These results have also been reported in other systematic reviews and meta-analyses all supporting the beneficial effects of lifestyle interventions, regardless of study design, on weight loss and weight maintenance, delay of T2DM onset and progression and decreased risk for CVD [24,27,28,[205][206][207][208][209][210], as well as reduced or eliminated need for anti-diabetic medications [27,127,128,148]. Both shorter-term (6-12 months) and longer-term (>12 months) studies showed that more intensive lifestyle interventions (i.e., medications alone vs medications plus diet plus 5-6 aerobic training sessions/week, duration 30-60 min, of which 2 to 3 sessions were combined aerobic and resistance training) led to greater HbA1c reduction (6.5% compared to 1% with less intensive interventions) [148][149][150] and significant reduction in antidiabetic medications (up to 73% with lifestyle interventions compared to 23% in the control group) [148].…”

“…The Look AHEAD Trial, the Diabetes Remission Clinical Trial (DiRECT) and the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) highlighted the potential for T2DM remission, defined as the maintenance of euglycemia (complete remission) or prediabetes level of glycemia (partial remission) with no diabetes medication for at least 1 year, with a weight loss of 15 kg or more within one year following a low or a very low-calorie diet, and also using meal replacements [125][126][127][128] in people undergoing weight loss treatment. In the Look AHEAD trial, when compared with the control group, the intensive lifestyle arm (more visits, 175 min/week unsupervised physical activity, dietary modification counseling, and a weight loss goal of 10%) resulted in at least partial diabetes remission in 12% of participants as compared with 2% in the control group [125].…”

Remission of type 2 diabetes: Perspectives of dietitians in Kuwait

“…The DIADEM study demonstrated that the TDR intervention is feasible in Qatar, which may translate to the Kuwaiti population, although North African participants made up a higher proportion than Middle Eastern participants which may indicate the reduced uptake of the intervention in patient population from the Gulf region [ 14 , 44 ]. This study also included an exercise component, which was advocated by the dietitians in the current study as a motivator.…”

Control de la glucosa y peso mediante una intervención intensiva de los estilos de vida en personas con diabesidad.

“…La consecución de los objetivos de las investigaciones estuvo dada principalmente por la remisión de la DM2, la reducción en el peso corporal de 5 al 10%. El estudio DIANEM-I [54] concuerda en que, mientras más anticipada se realice la intervención en los estilos de vida, se pueden alcanzar mejores resultados, la probabilidad de conseguir una remisión de diabetes mediada por la pérdida de peso es más factible mientras el diagnóstico de la enfermedad haya sido reciente y a más temprana edad.…”