Clinical trial NCT03174340: Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes
Official title: Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* twins

Primary outcomes:
measure: Prescription of insulin during the follow-up
timeFrame: 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.
Secondary outcomes:
measure: Control of glycemia
timeFrame: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
measure: Compliance with the exercise (in the exercise group only)
timeFrame: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Other outcomes:
measure: Timing of insulin treatment
timeFrame: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
measure: Gestational age at start of insulin treatment
timeFrame: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
measure: Dosage of long-acting insulin
timeFrame: From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
measure: Dosage of short-acting insulin
timeFrame: usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Locations:
Study officials:
affiliation: University Hospital, Geneva
name: Michel Boulvain
role: PRINCIPAL_INVESTIGATOR
References: