Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- University Hospital, Geneva
- Enrollment
- 109
- Primary Endpoint
- Prescription of insulin during the follow-up
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Michel Boulvain
Professor
University Hospital, Geneva
Eligibility Criteria
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
Outcomes
Primary Outcomes
Prescription of insulin during the follow-up
Time Frame: 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.
Secondary Outcomes
- Control of glycemia(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)(From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).)