Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
Primary Purpose
Diabetes Mellitus Type 2 in Obese
Status
Unknown status
Phase
Not Applicable
Locations
Barbados
Study Type
Interventional
Intervention
very low calorie liquid diet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 in Obese focused on measuring Diabetes Mellitus Remission, Prediabetic State, caloric restriction, weight loss, diet, Barbados
Eligibility Criteria
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
Sites / Locations
- Abundant Life Assembly
- Ellerton Wesleyan ChurchRecruiting
- River Road New Testament Church of GodRecruiting
- Mount of Praise Wesleyan ChurchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
very low calorie liquid diet
Arm Description
Phase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence
Outcomes
Primary Outcome Measures
change in weight
change in fasting glucose
change in Hba1C
Secondary Outcome Measures
change in waist circumference
change in blood pressure
both the systolic and diastolic pressures will be measured
change in blood pressure medication
Full Information
NCT ID
NCT03536377
First Posted
May 14, 2018
Last Updated
March 25, 2019
Sponsor
The University of The West Indies
1. Study Identification
Unique Protocol Identification Number
NCT03536377
Brief Title
Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
Official Title
Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of The West Indies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 in Obese
Keywords
Diabetes Mellitus Remission, Prediabetic State, caloric restriction, weight loss, diet, Barbados
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
very low calorie liquid diet
Arm Type
Experimental
Arm Description
Phase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence
Intervention Type
Other
Intervention Name(s)
very low calorie liquid diet
Intervention Description
Phase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material
Primary Outcome Measure Information:
Title
change in weight
Time Frame
enrolment, 12 weeks, 6 mths and 1 year
Title
change in fasting glucose
Time Frame
Enrolment, 12 weeks, 6 months, 1 year
Title
change in Hba1C
Time Frame
Enrolment, 12 weeks, 6 months, 1 year
Secondary Outcome Measure Information:
Title
change in waist circumference
Time Frame
Enrolment, 12 weeks, 6 months, 1 year
Title
change in blood pressure
Description
both the systolic and diastolic pressures will be measured
Time Frame
Enrolment, 12 weeks, 6 months, 1 year
Title
change in blood pressure medication
Time Frame
weekly for the first 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim R Quimby, MBBS, PhD
Phone
12464266416
Email
kim.quimby@cavehill.wui.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T Alafia Samuels, MBBS, PhD
Organizational Affiliation
George Alleyne Chronic Disease Research Centre, The University of the West Indies
Official's Role
Study Chair
Facility Information:
Facility Name
Abundant Life Assembly
City
Bridgetown
State/Province
Bank Hall, Saint Michael
Country
Barbados
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Williams, MBBS, MSc
Phone
1 246-5739166
Email
eepilwil@googlemail.com
Facility Name
Ellerton Wesleyan Church
City
Bridgetown
State/Province
Ellerton, Saint George
Country
Barbados
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francine Bowman-Jones, MBBS
Phone
1 246-436-3661
Email
franbeejay1205@gmail.com
Facility Name
River Road New Testament Church of God
City
Bridgetown
State/Province
River Road, Saint Michael
Country
Barbados
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Sobers-Grannum, MBBS, MSc
Phone
1 246-4266030
Email
Natasha.sobers-grannum@cavehill.uwi.edu
Facility Name
Mount of Praise Wesleyan Church
City
Bridgetown
State/Province
Tudor Bridge, Saint Michael
Country
Barbados
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Taitt, RN
Phone
1 246-4246929
Email
ggriffith188@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21656330
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.
Results Reference
background
PubMed Identifier
29221645
Citation
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.
Results Reference
background
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
35074020
Citation
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.
Results Reference
derived
PubMed Identifier
34454636
Citation
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.
Results Reference
derived
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Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
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