An interventional study of very low calorie liquid diet in Diabetes Mellitus Type 2 in Obese, sponsored by The University of The West Indies. Status unknown at 4 sites in Barbados. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by The University of The West Indies · Not applicable, Interventional, and Treatment
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.
1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 861 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →The University of The West Indies is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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
both the systolic and diastolic pressures will be measured
Time frame: Enrolment, 12 weeks, 6 months, 1 year
change in blood pressure medication
Time frame: weekly for the first 12 weeks
Plan to share: Undecided
Started Feb 2019 (actual). Primary completion is estimated for Aug 2020, 18 months after the start.
Of 415 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 18 months is below that.
Counting every sponsor, half of 466 studies reached it within 24 months; a quarter within 11 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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The University of The West Indies