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

NCT03536377 | Unknown

• 1 other identifier: BDRS2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus Type 2 in Obese

Keywords

Diabetes Mellitus Remission; Prediabetic State; caloric restriction; weight loss; diet; Barbados

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• change in waist circumference

  Enrolment, 12 weeks, 6 months, 1 year

• change in blood pressure

  Enrolment, 12 weeks, 6 months, 1 year

• change in blood pressure medication

  weekly for the first 12 weeks

Study Arms (1)

very low calorie liquid diet

EXPERIMENTAL

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

Other: very low calorie liquid diet

Interventions

very low calorie liquid diet OTHER

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

very low calorie liquid diet

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (4)

Abundant Life Assembly

Bridgetown, Bank Hall, Saint Michael, Barbados

NOT YET RECRUITING

Ellerton Wesleyan Church

Bridgetown, Ellerton, Saint George, Barbados

RECRUITING

River Road New Testament Church of God

Bridgetown, River Road, Saint Michael, Barbados

RECRUITING

Mount of Praise Wesleyan Church

Bridgetown, Tudor Bridge, Saint Michael, Barbados

RECRUITING

Related Publications (6)

• 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.

  PMID: 21656330 BACKGROUND

• 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.

  PMID: 29221645 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Quimby KR, Murphy MM, Harewood H, Howitt C, Hambleton I, Jeyaseelan SM, Greaves N, Sobers N. Adaptation of a community-based type-2 diabetes mellitus remission intervention during COVID-19: empowering persons living with diabetes to take control. Implement Sci Commun. 2022 Jan 24;3(1):5. doi: 10.1186/s43058-022-00255-9.

  PMID: 35074020 DERIVED

• Quimby KR, Sobers N, George C, Greaves N, Browman-Jones F, Samuels TA. Implementation of a community-based low-calorie dietary intervention for the induction of type-2 diabetes and pre-diabetes remission: a feasibility study utilising a type 2 hybrid design. Implement Sci Commun. 2021 Aug 28;2(1):95. doi: 10.1186/s43058-021-00196-9.

  PMID: 34454636 DERIVED

MeSH Terms

Conditions

Prediabetic State; Weight Loss

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• T Alafia Samuels, MBBS, PhD

  George Alleyne Chronic Disease Research Centre, The University of the West Indies

  STUDY CHAIR

Central Study Contacts

Kim R Quimby, MBBS, PhD

CONTACT

12464266416; kim.quimby@cavehill.wui.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: February 11, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 28, 2019

Record last verified: 2018-05

Locations

BA (4)