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

Sponsor

The University of The West Indies (Other)

Overall Status

Unknown status

CT.gov ID

NCT03536377

Collaborator

(none)

100

Enrollment

Locations

Arm

21.7

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2 in Obese	Other: very low calorie liquid diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 11, 2019

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

change in waist circumference [Enrolment, 12 weeks, 6 months, 1 year]
change in blood pressure [Enrolment, 12 weeks, 6 months, 1 year]
both the systolic and diastolic pressures will be measured
change in blood pressure medication [weekly for the first 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Abundant Life Assembly	Bridgetown	Bank Hall, Saint Michael	Barbados
2	Ellerton Wesleyan Church	Bridgetown	Ellerton, Saint George	Barbados
3	River Road New Testament Church of God	Bridgetown	River Road, Saint Michael	Barbados
4	Mount of Praise Wesleyan Church	Bridgetown	Tudor Bridge, Saint Michael	Barbados