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

The University of The West Indies

Status: Unknown

Conditions: Diabetes Mellitus Type 2 in Obese

Treatments: Other: very low calorie liquid diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03536377

BDRS2

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

very low calorie liquid diet

Experimental group

Description:

Phase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence

Treatment:

Other: very low calorie liquid diet