Diabetes Mellitus Type 2 in ObeseNCT03536377
Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
A study testing very low calorie liquid diet in people with Diabetes Mellitus Type 2 in Obese, run by The University of The West Indies at 4 sites in Barbados.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese
- What is being tested?
- very low calorie liquid diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesBarbados
- Study dates
- 11 Feb 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insulin use
- Substance abuse
- Current cancer diagnosis
- myocardial infarction within last 6 month
- learning difficulties
- current treatment with anti-obesity drugs
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Barbados4 sites, 4 recruiting
- Not yet recruiting
Abundant Life Assembly
Bridgetown, Bank Hall, Saint Michael
Lynda Williams, MBBS, MSc, 1 246-5739166, eepilwil@googlemail.com
- Recruiting
Ellerton Wesleyan Church
Bridgetown, Ellerton, Saint George
Francine Bowman-Jones, MBBS, 1 246-436-3661, franbeejay1205@gmail.com
- Recruiting
River Road New Testament Church of God
Bridgetown, River Road, Saint Michael
Natasha Sobers-Grannum, MBBS, MSc, 1 246-4266030, Natasha.sobers-grannum@cavehill.uwi.edu
- Recruiting
Mount of Praise Wesleyan Church
Bridgetown, Tudor Bridge, Saint Michael
Susan Taitt, RN, 1 246-4246929, ggriffith188@gmail.com
About this study
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.
Read more
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.
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Being tested
- very low calorie liquid diet
- Keywords
- Diabetes Mellitus Remission, Prediabetic State, caloric restriction, weight loss, diet, Barbados
- Medical subject headings
- Prediabetic State, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
very low calorie liquid dietOther
Phase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material
| Study group | Role | What they receive |
|---|---|---|
| very low calorie liquid diet | Experimental | Phase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence Receives: Other: very low calorie liquid diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight
Measured: enrolment, 12 weeks, 6 mths and 1 year
change in fasting glucose
Measured: Enrolment, 12 weeks, 6 months, 1 year
change in Hba1C
Measured: Enrolment, 12 weeks, 6 months, 1 year
Secondary outcomes (3)
change in waist circumference
Measured: Enrolment, 12 weeks, 6 months, 1 year
change in blood pressure
both the systolic and diastolic pressures will be measured
Measured: Enrolment, 12 weeks, 6 months, 1 year
change in blood pressure medication
Measured: weekly for the first 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start11 Feb 2019
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- T Alafia Samuels, MBBS, PhD, Study chair, George Alleyne Chronic Disease Research Centre, The University of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536377
- Sponsor's protocol ID
- BDRS2
- Status last verified
- May 2018
- First submitted
- 14 May 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21656330Lean 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.
PubMed 29221645Unwin 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.
PubMed 35074020Quimby 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.
PubMed 34454636
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
- ClinicalTrials.gov ID
- NCT03536377
- Acronym / sponsor ID
- BDRS2
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Keywords
- Diabetes Mellitus Remission, Prediabetic State, caloric restriction, weight loss, diet, Barbados
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| very low calorie liquid diet | Experimental | Other: very low calorie liquid dietPhase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Insulin use
- Substance abuse
- Current cancer diagnosis
- myocardial infarction within last 6 month
- learning difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| very low calorie liquid dietPhase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material | Other | very low calorie liquid diet |
Primary outcome
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
3 secondary outcomes
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
change in blood pressure medication
Time frame: weekly for the first 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Background: PubMed 21656330Lim 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.
- Background: PubMed 29221645Lean 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.
- BackgroundUnwin 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
- BackgroundKaren 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
- Derived from this study: PubMed 35074020Quimby 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.
- Derived from this study: PubMed 34454636Quimby 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
T Alafia Samuels, MBBS, PhD study chair
George Alleyne Chronic Disease Research Centre, The University of the West Indies
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing very low calorie liquid diet in people with Diabetes Mellitus Type 2 in Obese, run by The University of The West Indies at 4 sites in Barbados.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Barbados. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim R Quimby, MBBS, PhD (12464266416, kim.quimby@cavehill.wui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in weight (time frame: enrolment, 12 weeks, 6 mths and 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536377, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.