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Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis (GDM)

28 de novembro de 2011 atualizado por: Naomi Meyerstein, Soroka University Medical Center

Identification of Risk Factors for DM Type 2 in Women Post GDM Diagnosis and Its Prevention by Changing Life Style

Diabetes Mellitus (DM) is a chronic metabolic disorder with increasing incidence and long term complications. Its incidence differs in various ethnic populations.Gestational DM (GDM) is diagnosed when impaired glucose tolerance (IGT) is first detected during pregnancy. GDM incidence in Jewish and Bedouin women has been rising in recent years. It has been reported in many studies that women who had been diagnosed with GDM are more prone to GDM in their next pregnancies and to DM Type 2.

Appropriate changes in everyday diet and physical exercise may reduce the chances for future GDM and type 2 DM.

The investigators aim was to determine GDM frequency in the Negev area in Jewish and Bedouin populations and to construct a plan for follow up and reduce future problems by changing their life style.

Visão geral do estudo

Descrição detalhada

Diabetes Mellitus is a very common chronic metabolic disorder,currently an epidemic with correlation to obesity. DM frequency differs as a function of population characteristics factors. In Israel it is more prevalent in Jews than in Bedouins. However, lately, there has been a rise in DM frequency in the Bedouin population. This rise is probably due to the change in life style from the traditional way of life towards a western one, characterized by change in food habits and decrease in physical activity. This combination may lead to increased body mass index (BMI)and to DM.

Many studies report higher incidence of DM type 2 following Gestational Diabetes Mellitus (GDM). GDM is defined as glucose intolerance which is detected during pregnancy in healthy women. Its frequency varies between 1 to 14% in pregnant women in different populations. Although usually glucose intolerance disappears after delivery,many of these women may develop future GMD or DM type 2. This can be delayed or even prevented by appropriate diet and increased physical activity.

The aim of our study was:

  1. To determine GDM frequency in Jewish and Bedouin populations in the Negev area in southern Israel.
  2. To approach Jewish and Bedouin GDM women before discharge from the hospital and invite them to join the study and divide them into intervention group and control respectively.
  3. To study whether intervention in life style leads to similar results in both populations.
  4. To propose a model for predicting persistent lifestyle change intervention.

The study included 180 women diagnosed with GDM ,133 Jewish and 47 Bedouin women.The women were divided in two groups, an intervention group (77 Jewish and 26 Bedouin) and control ones (56 Jewish and 21 Bedouin women). At their first visit, 3 months after delivery all women filled forms about demographic data, nutrition and physical habits. All of them, including the control group were given full information about GDM and increased risk for DM.

All the women signed their informed consent forms for participation in the study. The intervention group had several group meetings every several months. Metabolic parameters were determined, including plasma insulin ,glucose and lipids levels.Height, weight, BMI, blood pressure and abdominal circumference were measured too. The same parameters were determined one and two years post partum. The intervention group had several group meetings every several months with a dietician and a physical exercise instructor.

Tipo de estudo

Intervencional

Inscrição (Real)

180

Estágio

  • Não aplicável

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

18 anos a 43 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Diagnosis of gestational diabetes.

Exclusion Criteria:

  • Diabetes Mellitus

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: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Post GDM follow-up group.
Every several months the women had instructions and checkups.
Outros nomes:
  • Jew and Bedouin women with recent GDM in the Negev area.
Experimental: lifestyle intervention group.
The women in this group had participated in lifestyle intervention by diet instructions and physical exercise program.
Every several months the women had instructions and checkups.
Outros nomes:
  • Jew and Bedouin women with recent GDM in the Negev area.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).
Prazo: Determination of HOMA after one year.
The metabolic parameters included glucose and insulin levels, to enable calculations of HOMA IR. (Homeostasis Model Assessment of Insulin Resistance).
Determination of HOMA after one year.
Change in HOMA.
Prazo: Detrmination of HOMA after two years.
HOMA calculations post partum.
Detrmination of HOMA after two years.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Determinations of blood lipids .
Prazo: Post partum lipids levels after one year.
Determinations of total lipids , total cholesterol , HDL, LDL and triglycerides levels.
Post partum lipids levels after one year.
Change in lipids levels after two years post partum.
Prazo: 2 years after delivery.
Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.
2 years after delivery.
Post partum BMI changes.
Prazo: one year after delivery.
BMI assessments after one year.
one year after delivery.
BMI changes after delivery.
Prazo: Two years after delivery.
BMI assessments after delivery.
Two years after delivery.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este 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 março de 2007

Conclusão Primária (Real)

1 de março de 2010

Conclusão do estudo (Real)

1 de abril de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

22 de novembro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de novembro de 2011

Primeira postagem (Estimativa)

29 de novembro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

29 de novembro de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de novembro de 2011

Última verificação

1 de novembro de 2011

Mais Informações

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 .

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