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

Diabetes Mellitus Type 2 in Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536377
• Other study ID #: BDRS2
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: December 2020

Study information

• Verified date: May 2018
• Source: The University of The West Indies
• Contact: Kim R Quimby, MBBS, PhD
• Phone: 12464266416
• Email: kim.quimby[@]cavehill.wui.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 in Obese
• Diabetes Mellitus, Type 2

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Barbados, 

References & Publications (4)

Karen Bynoe, Maddy Murphy, Charles Taylor, Andre Greenidge, Melissa Abed, Nigel Unwin. The Barbados Diabetes Reversal Study Preliminary Results https://www.cavehill.uwi.edu/fms/resources/cme/78th-cme-presentations/karen-bynoe-barbados-diabetes-reversal-study.aspx

Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5. — View Citation

Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia. 2011 Oct;54(10):2506-14. doi: 10.1007/s00125-011-2204-7. Epub 2011 Jun 9. — View Citation

Unwin N, Rose AMC, George KS, Hambleton IR, Howitt C. The Barbados Health of the Nation Survey: Core Findings. Chronic Disease Research Centre, The University of the West Indies and the Barbados Ministry of Health: St Michael, Barbados, January 2015; 48 pp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in weight		enrolment, 12 weeks, 6 mths and 1 year
Primary	change in fasting glucose		Enrolment, 12 weeks, 6 months, 1 year
Primary	change in Hba1C		Enrolment, 12 weeks, 6 months, 1 year
Secondary	change in waist circumference		Enrolment, 12 weeks, 6 months, 1 year
Secondary	change in blood pressure	both the systolic and diastolic pressures will be measured	Enrolment, 12 weeks, 6 months, 1 year
Secondary	change in blood pressure medication		weekly for the first 12 weeks