Diabetes Intervention Accentuating Diet and Enhancing Metabolism

Study Overview
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Brief Summary
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Diabetes is one of the greatest challenges faced by healthcare services worldwide. It is associated with serious complications such as heart attacks, stroke, and peripheral artery disease as well as kidney disease, eye disease, and nerve dysfunction. Data from weight loss with bariatric surgery suggest that with the appropriate intervention, it should be possible to reverse diabetes and that the earlier the intervention occurs, the greater the chances of placing diabetes into remission. There is now a need to translate this knowledge into the medical care of younger patients with early diabetes who are overweight/obese. The aim of this study is to see if younger adult patients with overweight/obesity and type 2 diabetes who are participants in a programme incorporating a low energy diet and physical activity (lifestyle) will lower their weight, cardiovascular risk and improve their glycaemic control as compared to the usual care.

Detailed Description
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The aim of the proposed study is to conduct a pragmatic randomised controlled clinical trial randomising young adult patients with obesity and type 2 diabetes to an intervention incorporating a low calorie diet and physical activity or usual care. The investigators hypothesise that patients in the low calorie intervention arm will have greater weight reduction leading to significant improvement in glycaemic control and cardiovascular risk. The primary outcome will be weight loss. The low calorie diet intervention arm is designed to achieve and maintain significant weight loss through decreased calorie intake, increased physical activity, and behaviour change. Usual care will include routine advice about diet and physical activity. Secondary outcomes include diabetes control, body composition, and quality of life.

Official Title
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A Randomised Controlled Trial Assessing the Impact of Low Calorie Diet and Activity on Body Weight and Glycaemia in Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Low Energy Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus (based on ADA diagnostic criteria) ; Diabetes of ≤ 3-year duration; BMI >27.0 kg/m² (based on WHO cut-points for ethnicity 119); Men and women; Age 18-50 years; Originating from the Middle East and North Africa region and resident in Qatar; Able to commit to the study duration; Able to give informed consent and willing to participate in the study. Exclusion Criteria: Type 1 diabetes mellitus based on clinical history; Cardiovascular event in the previous 6 months; Chronic kidney disease stage 3b or greater (eGFR <30 mL/min/1.73m²); Currently pregnant, lactating, or planning pregnancy within the study period; Any condition precipitating fluid overload such as heart failure (NYHA class > I) and liver cirrhosis; Significant previously diagnosed psychiatric disorder (e.g. schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder); Uncontrolled depression (based on hospital anxiety and depression scale); Uncontrolled epilepsy; Known lactose intolerance; Severe arthritis preventing walking; Active gout; Active gallstone disease or known asymptomatic gallstones.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>The intervention includes the use of Low Energy Diet replacement products in combination with physical activity, followed by gradual introduction of food, and increasing physical activity. Behavioural support for the lifestyle intervention will also be provided. | Dietary Supplement: Low Energy Diet<br>* Low Energy Diet<br>|
| No Intervention: Usual Care<br>This will be based on current clinical practice aiming to reduce diabetes symptoms and complications, and general recommendations on diet and physical activity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight change (weight in kilograms) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control | HbA1c measured biochemically (percentage units) | 12 months | 
| Patient reported outcomes | Euro-QoL-5D | 12 months |