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 : Unknown
Verified May 2018 by The University of The West Indies.
Recruitment status was: Recruiting
First Posted : May 24, 2018
Last Update Posted : March 28, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- change in weight [ Time Frame: enrolment, 12 weeks, 6 mths and 1 year ]
- change in fasting glucose [ Time Frame: Enrolment, 12 weeks, 6 months, 1 year ]
- change in Hba1C [ Time Frame: Enrolment, 12 weeks, 6 months, 1 year ]
- change in waist circumference [ Time Frame: Enrolment, 12 weeks, 6 months, 1 year ]
- change in blood pressure [ Time Frame: Enrolment, 12 weeks, 6 months, 1 year ]both the systolic and diastolic pressures will be measured
- change in blood pressure medication [ Time Frame: weekly for the first 12 weeks ]
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
|Contact: Kim R Quimby, MBBS, PhDemail@example.com|
|Abundant Life Assembly||Not yet recruiting|
|Bridgetown, Bank Hall, Saint Michael, Barbados|
|Contact: Lynda Williams, MBBS, MSc 1 246-5739166 firstname.lastname@example.org|
|Ellerton Wesleyan Church||Recruiting|
|Bridgetown, Ellerton, Saint George, Barbados|
|Contact: Francine Bowman-Jones, MBBS 1 246-436-3661 email@example.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.firstname.lastname@example.org|
|Mount of Praise Wesleyan Church||Recruiting|
|Bridgetown, Tudor Bridge, Saint Michael, Barbados|
|Contact: Susan Taitt, RN 1 246-4246929 email@example.com|
|Study Chair:||T Alafia Samuels, MBBS, PhD||George Alleyne Chronic Disease Research Centre, The University of the West Indies|