Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes
1 de junho de 2017 atualizado por: Michel Boulvain, University Hospital, Geneva
The main objective is to evaluate the effect of therapeutic exercise program on blood glucose regulation in women with gestational diabetes mellitus (GDM) who are assigned to diet-and-exercise, compared to diet only (usual treatment).
The primary outcome is the need for insulin treatment in the two groups.
Visão geral do estudo
Descrição detalhada
In women with gestational diabetes, light to moderate daily physical activity may a useful therapeutic approach to improve the control of glycaemia and decrease the need for prescription of insulin. Increased physical activity in pregnant women with gestational diabetes is expected to decrease the mother and child morbidity associated with gestational diabetes, but also to improve the general health status of the mother and the child.
The objectives of this randomized trial are:
- To evaluate the effect of therapeutic exercise program on blood glucose regulation in women with GDM who are assigned to diet-and-exercise protocol.
- To demonstrate the feasibility of the therapeutic exercise treatment and the possibility of using the exercise program as an optional therapeutic approach for women with GDM.
Tipo de estudo
Intervencional
Inscrição (Real)
109
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 50 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- gestational diabetes, based on the criteria of Coustan-Carpenter, then on the International Association Diabetes Pregnancy Study Groups (IADPSG )
Exclusion Criteria:
- pre-existing diabetes
- twins
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Exercise + diet
Exercise intervention: During the first session a standardized exercise prescription will be discussed with the participant. The exercise program will be of a moderate intensity, at less than 140 heart beats/min (which corresponds to 60% of the calculated maximum heart rate (HRmax) or 50% maximum oxygen volume (VO2max) ). A session of 30 to 60 minutes/week will be organised.
This is in addition to the diet (see below, control group) |
Once per week, participants will be enrolled in supervised group exercise intervention.
They will be encouraged in walking 45 minutes per day
|
|
Sem intervenção: Diet only
Participants will receive diet counselling according to their characteristics.
The usual recommendation is to have a fractioned normocaloric diet (unless the dietician identify a grossly hypercaloric diet), with low fat and increase in fibers content.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Prescription of insulin during the follow-up
Prazo: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point.
|
The primary outcome will include any amount (dosage) of insulin and any frequency of injection.
Prescription of insulin is considered when glycaemia is above 5.3 mmol/L fasting and/or above 8.0 at 1 hour after the meal.
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Control of glycemia
Prazo: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
4 times per day, participants will check their blood sugar level.
The investigators will record these blood sugar levels and consider as normal if below 5.3 mmol/L fasting and below 8.0 at 1 hour after the meal.
Suboptimal glycemic control will be defined as 2 or more glycemia above these target values; good control will be defined as less than 2 values above the thresholds.
The variable "good glycemic control" will be coded "yes" if the above criteria (<2 abnormal values) are met, and "no" otherwise (>=2 abnormal values)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Compliance with the exercise (in the exercise group only)
Prazo: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Satisfactory compliance will be defined as walking at least 5000 steps/day 5 days a week and attending at 50% or more of the weekly supervised exercise program.
The variable "compliance" will be coded "yes" if both the above criteria are met, and "no" otherwise
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Timing of insulin treatment
Prazo: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
To better understand the effect of the intervention on the primary outcome, prescription of insulin), the investigators will compare between groups: Time between randomization and insulin prescription (days) |
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Gestational age at start of insulin treatment
Prazo: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
the investigators will compare between groups: Gestational age at start of insulin treatment (weeks) (mean ± SD)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Dosage of long-acting insulin
Prazo: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Maximal dose of long-acting insulin per day (mean ± SD)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Dosage of short-acting insulin
Prazo: usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Maximal dose of short-acting insulin per day (mean ± SD)
|
usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Michel Boulvain, Hôpitaux Universitaires de Genève
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 (Real)
21 de fevereiro de 2008
Conclusão Primária (Real)
25 de abril de 2013
Conclusão do estudo (Real)
19 de junho de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
24 de janeiro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2017
Primeira postagem (Real)
2 de junho de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de junho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de junho de 2017
Última verificação
1 de junho de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 07-080 MATPED 07-021
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Meta-analysis with the Cochrane Collaboration, if individual patient data are needed
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