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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03536377
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Bank Hall, Saint Michael
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Bridgetown, Bank Hall, Saint Michael, Barbados
- Ainda não está recrutando
- Abundant Life Assembly
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Contato:
- Lynda Williams, MBBS, MSc
- Número de telefone: 1 246-5739166
- E-mail: eepilwil@googlemail.com
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Ellerton, Saint George
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Bridgetown, Ellerton, Saint George, Barbados
- Recrutamento
- Ellerton Wesleyan Church
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Contato:
- Francine Bowman-Jones, MBBS
- Número de telefone: 1 246-436-3661
- E-mail: franbeejay1205@gmail.com
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River Road, Saint Michael
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Bridgetown, River Road, Saint Michael, Barbados
- Recrutamento
- River Road New Testament Church of God
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Contato:
- Natasha Sobers-Grannum, MBBS, MSc
- Número de telefone: 1 246-4266030
- E-mail: Natasha.sobers-grannum@cavehill.uwi.edu
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Tudor Bridge, Saint Michael
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Bridgetown, Tudor Bridge, Saint Michael, Barbados
- Recrutamento
- Mount of Praise Wesleyan Church
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Contato:
- Susan Taitt, RN
- Número de telefone: 1 246-4246929
- E-mail: ggriffith188@gmail.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
change in weight
Prazo: enrolment, 12 weeks, 6 mths and 1 year
|
enrolment, 12 weeks, 6 mths and 1 year
|
change in fasting glucose
Prazo: Enrolment, 12 weeks, 6 months, 1 year
|
Enrolment, 12 weeks, 6 months, 1 year
|
change in Hba1C
Prazo: Enrolment, 12 weeks, 6 months, 1 year
|
Enrolment, 12 weeks, 6 months, 1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
change in waist circumference
Prazo: Enrolment, 12 weeks, 6 months, 1 year
|
Enrolment, 12 weeks, 6 months, 1 year
|
|
change in blood pressure
Prazo: Enrolment, 12 weeks, 6 months, 1 year
|
both the systolic and diastolic pressures will be measured
|
Enrolment, 12 weeks, 6 months, 1 year
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change in blood pressure medication
Prazo: weekly for the first 12 weeks
|
weekly for the first 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: T Alafia Samuels, MBBS, PhD, George Alleyne Chronic Disease Research Centre, The University of the West Indies
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BDRS2
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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