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

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ClinicalTrials.gov Identifier: NCT03536377
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
The University of The West Indies

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : February 11, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. change in weight [ Time Frame: enrolment, 12 weeks, 6 mths and 1 year ]
  2. change in fasting glucose [ Time Frame: Enrolment, 12 weeks, 6 months, 1 year ]
  3. change in Hba1C [ Time Frame: Enrolment, 12 weeks, 6 months, 1 year ]

Secondary Outcome Measures :
  1. change in waist circumference [ Time Frame: Enrolment, 12 weeks, 6 months, 1 year ]
  2. change in blood pressure [ Time Frame: Enrolment, 12 weeks, 6 months, 1 year ]
    both the systolic and diastolic pressures will be measured

  3. change in blood pressure medication [ Time Frame: weekly for the first 12 weeks ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536377


Contacts
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Contact: Kim R Quimby, MBBS, PhD 12464266416 kim.quimby@cavehill.wui.edu

Locations
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Barbados
Abundant Life Assembly Not yet recruiting
Bridgetown, Bank Hall, Saint Michael, Barbados
Contact: Lynda Williams, MBBS, MSc    1 246-5739166    eepilwil@googlemail.com   
Ellerton Wesleyan Church Recruiting
Bridgetown, Ellerton, Saint George, Barbados
Contact: Francine Bowman-Jones, MBBS    1 246-436-3661    franbeejay1205@gmail.com   
River Road New Testament Church of God Recruiting
Bridgetown, River Road, Saint Michael, Barbados
Contact: Natasha Sobers-Grannum, MBBS, MSc    1 246-4266030    Natasha.sobers-grannum@cavehill.uwi.edu   
Mount of Praise Wesleyan Church Recruiting
Bridgetown, Tudor Bridge, Saint Michael, Barbados
Contact: Susan Taitt, RN    1 246-4246929    ggriffith188@gmail.com   
Sponsors and Collaborators
The University of The West Indies
Investigators
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Study Chair: T Alafia Samuels, MBBS, PhD George Alleyne Chronic Disease Research Centre, The University of the West Indies

Publications:
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Responsible Party: The University of The West Indies
ClinicalTrials.gov Identifier: NCT03536377     History of Changes
Other Study ID Numbers: BDRS2
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of The West Indies:
Diabetes Mellitus Remission
Prediabetic State
caloric restriction
weight loss
diet
Barbados

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases