Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Diabetic Educational Eating Plan (DEEP)

28 de agosto de 2012 atualizado por: Yunsheng Ma, University of Massachusetts, Worcester

Applicability of a Low Glycemic Index Diet in Diabetes

By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention, to reduce dietary GI in patients with type 2 diabetes, and to compare it with a nutritionist-delivered standard American Diabetes Association (ADA) diet intervention. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood lipids, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention.

Primary hypotheses:

1. Recruitment and retention rates for the low GI intervention will be satisfactory.

Secondary hypotheses:

  1. Participants in the low GI intervention group will show more favorable changes in physiological measures than participants in the ADA diet group.
  2. Participants in the low GI group will be successful in lowering the GI of their diet.
  3. Participants will find the intervention acceptable.

Visão geral do estudo

Descrição detalhada

The glycemic index (GI) is a ranking of carbohydrate containing foods according to the rate at which they raise blood glucose levels after eating. A recent meta-analysis of randomized clinical trials (RCT) suggests that choosing low GI foods has a small but clinically useful effect on medium-term glycemic control in patients with type 2 diabetes. However, in most of the reviewed RCTs, patients were fed experimental diets and therefore there is still controversy over the applicability of GI in the clinical setting for management of diabetes. In addition, there is no evidence that long-term consumption of a low GI diet will contribute to improved glycemic control in people with diabetes.

Our ultimate goal for a future larger RCT is to evaluate the long-term effects of using low GI diet in type 2 diabetics. The primary outcome variable of the future large trial will be glycosylated hemoglobin levels (HbA1c), a measure reflecting average glycemic level during the preceding 2-3 months. The proposed feasibility study will recruit 40 patients with type 2 diabetes and will randomly assign them to one of two groups: a low GI nutrition education group (low GI group) and a standard ADA dietary education group as the control group (ADA group) (20 patients in each group).

For both groups, the intervention phase will last 6 months and consist of an initial group session, an individual session, and then four group counseling sessions. The follow-up phase will be six months and consist of two group booster sessions, one at 8-months and another at 10-months. The low GI nutritional education will be primarily targeted at a low GI diet. The focus is not on decreasing total carbohydrate intake, but rather encouraging patients to substitute low GI foods for high GI foods. The dietary intervention will be based on a patient-centered counseling model which has been demonstrated to facilitate health behavior change. Data collection points coincide with two phases of the intervention. Assessments, including demographics, anthropometric measurements, diet and physical activity recalls, and clinical data, will be conducted at baseline, and at 6 and 12 months after randomization, with blood samples collected at each interval. We will track response to recruitment, adherence, and retention. Quantitative and qualitative methods will be used to assess acceptability of the intervention.

The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention to reduce dietary GI in patients with type 2 diabetes. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention.

By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. Testing the feasibility of such a program and its potential impact would be an important step towards an RO1 application to the NIH.

Tipo de estudo

Intervencional

Inscrição (Real)

40

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Massachusetts
      • Worcester, Massachusetts, Estados Unidos, 01655
        • University of Massachusetts Medical School

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

21 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Diagnosis of type II diabetes in the medical chart
  • HbA1c level >= 7 (an indication of poor control of diabetes)
  • Currently being treated with diet, oral hypoglycemic agents and/or insulin
  • At least 21 years old
  • Telephone in home or easy access to one
  • Able to understand study protocol
  • Understands and can provide informed consent
  • Physician's approval to participate in study
  • Has a blood glucose machine or a prescription for one from their physician
  • Able to speak and read English
  • Willing to be randomized to either of the two study groups
  • Able to participate in the study for a one year length of time.

Exclusion Criteria:

  • Pregnant or planning to become pregnant during the study
  • Unable or unwilling to provide informed consent
  • Plans to move out of the area within the 12-month study period
  • Required intermittent glucocorticoid therapy within the past 3 months
  • Documented acute coronary event (MI or unstable angina) within the past 6 months
  • Diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g. Crohn's disease, ulcerative colitis, end-stage renal disease)
  • Diagnosis of a psychiatric illness (i.e. dementia, psychiatric hospitalization or suicidality within the past 5 years). We will not exclude individuals with a diagnosis of depression or patients taking anti-depressants.
  • Following a low-carbohydrate high fat dietary regimen such as the Atkins diet, or currently following the South Beach Diet
  • Legally blind or has significant visual impairments

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: ADA diet
Patients will be encouarged to consume foods consisted with ADA dietary recommendation
ADA dietary education
Experimental: Low-GI
a low GI dietary education
low-GI education

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention
Prazo: one year
one year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Yunsheng Ma, MD, Ph.D., Division of Preventive & Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2005

Conclusão Primária (Real)

1 de agosto de 2012

Conclusão do estudo (Real)

1 de agosto de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

14 de maio de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de maio de 2007

Primeira postagem (Estimativa)

16 de maio de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

30 de agosto de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de agosto de 2012

Última verificação

1 de agosto de 2012

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 5P30DK032520-24 (Concessão/Contrato do NIH dos EUA)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em ADA diet

3
Se inscrever