Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community

Study Overview
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Brief Summary
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The complications associated with uncontrolled type-2 diabetes mellitus (T2DM) are numerous; reducing the quality of life for the patient and consuming a considerable portion of healthcare finances. The Health of the Nation (HotN) 2011 study reported that 50% of the Barbadian population >65years old had a diagnosis of T2DM and that two-thirds of the population were overweight - which is a risk factor for the development of T2DM. Encouraged by the success of the Counterpoint study in the United Kingdom (UK), the Barbados Diabetes Reversal Study 1 (BDRS1) was established using a similar protocol; the aim of which was to evaluate the feasibility of implementing a very low calorie diet to reverse T2DM in Barbados. At the end of the 8-week intervention period, the 25 participants had achieved an average weight loss of 10.1kg (22lbs). This was accompanied by an increase in the number of participants whose fasting blood sugars were now within normal range despite being off of their diabetes medication; and a decrease in the number of participants taking blood pressure medication. Participants transitioned to a solid diet over a 4-week period, with guidance on health dietary habits and regular exercise routines. The benefits accrued during the intervention phase were preserved at the end of the transition period. We now propose the Barbados Diabetes Remission Study 2 (BDRS2) as a sustainable community intervention - utilizing the local church as the community site. We hypothesize that this will enhance reach while reducing the cost of the study and will also facilitate the structures necessary for the social support of the participant.

Official Title
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Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community

Conditions
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Diabetes Mellitus Type 2 in Obese

Intervention / Treatment
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* Other: very low calorie liquid diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 20 - 70 years old, all ethnicities Diagnosis of T2DM for <6 years as defined by the American Diabetes Association Diagnosis of pre-diabetes as defined by the American Diabetes Association Body Mass index (BMI) of 27 kg/m2 and over Exclusion Criteria: Insulin use Substance abuse Current cancer diagnosis myocardial infarction within last 6 month learning difficulties current treatment with anti-obesity drugs diagnosed eating disorder or purging HbA1c > 10% pregnant/considering pregnancy evidence of liver disease (including liver enzymes > 3 times above normal values) evidence of renal disease (creatinine of > 150 mmol/l) persons who have required hospitalisation for depression, or are on antipsychotic drugs

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: very low calorie liquid diet<br>Phase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence | Other: very low calorie liquid diet<br>* Phase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in weight |  | enrolment, 12 weeks, 6 mths and 1 year | 
| change in fasting glucose |  | Enrolment, 12 weeks, 6 months, 1 year | 
| change in Hba1C |  | Enrolment, 12 weeks, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in waist circumference |  | Enrolment, 12 weeks, 6 months, 1 year | 
| change in blood pressure | both the systolic and diastolic pressures will be measured | Enrolment, 12 weeks, 6 months, 1 year | 
| change in blood pressure medication |  | weekly for the first 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, Diabetes Mellitus Remission, Prediabetic State, caloric restriction, weight loss, Barbados