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

March 25, 2019 updated by: The University of The West Indies

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Barbados
    • Bank Hall, Saint Michael
      • Bridgetown, Bank Hall, Saint Michael, Barbados
        • Not yet recruiting
        • Abundant Life Assembly
        • Contact:
    • Ellerton, Saint George
      • Bridgetown, Ellerton, Saint George, Barbados
        • Recruiting
        • Ellerton Wesleyan Church
        • Contact:
    • River Road, Saint Michael
      • Bridgetown, River Road, Saint Michael, Barbados
    • Tudor Bridge, Saint Michael
      • Bridgetown, Tudor Bridge, Saint Michael, Barbados
        • Recruiting
        • Mount of Praise Wesleyan Church
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Investigators

  • Study Chair: T Alafia Samuels, MBBS, PhD, George Alleyne Chronic Disease Research Centre, The University of the West Indies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDRS2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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