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

NCT03536377 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-03-28

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus Type 2 in Obese

Interventions

OTHER

very low calorie liquid diet

Phase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material

Sponsors & Collaborators

  • The University of The West Indies

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2020-08-31
Completion
2020-12-31

Countries

  • Barbados

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03536377 on ClinicalTrials.gov