Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Bank Hall, Saint Michael
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Bridgetown、Bank Hall, Saint Michael、バルバドス
- まだ募集していません
- Abundant Life Assembly
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コンタクト：
- Lynda Williams, MBBS, MSc
- 電話番号：1 246-5739166
- メール：eepilwil@googlemail.com
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Ellerton, Saint George
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Bridgetown、Ellerton, Saint George、バルバドス
- 募集
- Ellerton Wesleyan Church
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コンタクト：
- Francine Bowman-Jones, MBBS
- 電話番号：1 246-436-3661
- メール：franbeejay1205@gmail.com
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River Road, Saint Michael
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Bridgetown、River Road, Saint Michael、バルバドス
- 募集
- River Road New Testament Church of God
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コンタクト：
- Natasha Sobers-Grannum, MBBS, MSc
- 電話番号：1 246-4266030
- メール：Natasha.sobers-grannum@cavehill.uwi.edu
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Tudor Bridge, Saint Michael
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Bridgetown、Tudor Bridge, Saint Michael、バルバドス
- 募集
- Mount of Praise Wesleyan Church
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コンタクト：
- Susan Taitt, RN
- 電話番号：1 246-4246929
- メール：ggriffith188@gmail.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：very low calorie liquid diet
Phase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence
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Phase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
change in weight
時間枠：enrolment, 12 weeks, 6 mths and 1 year
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enrolment, 12 weeks, 6 mths and 1 year
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change in fasting glucose
時間枠：Enrolment, 12 weeks, 6 months, 1 year
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Enrolment, 12 weeks, 6 months, 1 year
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change in Hba1C
時間枠：Enrolment, 12 weeks, 6 months, 1 year
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Enrolment, 12 weeks, 6 months, 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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change in waist circumference
時間枠：Enrolment, 12 weeks, 6 months, 1 year
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Enrolment, 12 weeks, 6 months, 1 year
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change in blood pressure
時間枠：Enrolment, 12 weeks, 6 months, 1 year
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both the systolic and diastolic pressures will be measured
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Enrolment, 12 weeks, 6 months, 1 year
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change in blood pressure medication
時間枠：weekly for the first 12 weeks
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weekly for the first 12 weeks
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協力者と研究者
捜査官
- スタディチェア：T Alafia Samuels, MBBS, PhD、George Alleyne Chronic Disease Research Centre, The University of the West Indies
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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