Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
NCT ID: NCT03536377
Last Updated: 2019-03-28
Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-02-11
2020-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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very low calorie liquid diet
Phase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence
very low calorie liquid diet
Phase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material
Interventions
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very low calorie liquid diet
Phase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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The University of The West Indies
OTHER
Responsible Party
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Principal Investigators
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T Alafia Samuels, MBBS, PhD
Role: STUDY_CHAIR
George Alleyne Chronic Disease Research Centre, The University of the West Indies
Locations
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Abundant Life Assembly
Bridgetown, Bank Hall, Saint Michael, Barbados
Ellerton Wesleyan Church
Bridgetown, Ellerton, Saint George, Barbados
River Road New Testament Church of God
Bridgetown, River Road, Saint Michael, Barbados
Mount of Praise Wesleyan Church
Bridgetown, Tudor Bridge, Saint Michael, Barbados
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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
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
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.
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.
Other Identifiers
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BDRS2
Identifier Type: -
Identifier Source: org_study_id
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