Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes

Not Applicable

Completed

• Conditions: Gestational Diabetes

• Registration Number: NCT03174340
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2008-02-21
• Primary Completion: 2013-04-25
• Study Completion: 2013-06-19
• Study First Submitted: 2017-01-24
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Study First Posted: 2017-06-02
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prescription of insulin during the follow-up	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 Outcome Measures

Name	Time	Method
Control of glycemia	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)
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).	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