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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174340
• Other study ID #: 07-080 MATPED 07-021
• Status: Completed
• Phase: N/A
• First received: January 24, 2017
• Last updated: June 1, 2017
• Start date: February 21, 2008
• Est. completion date: June 19, 2013

Study information

• Verified date: June 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 19, 2013
• Est. primary completion date: April 25, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Exercise
Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Timing of insulin treatment	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).
Other	Gestational age at start of insulin treatment	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).
Other	Dosage of long-acting insulin	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).
Other	Dosage of short-acting insulin	Maximal dose of short-acting insulin per day (mean ± SD)	usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
Primary	Prescription of insulin during the follow-up	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.
Secondary	Control of glycemia	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).
Secondary	Compliance with the exercise (in the exercise group only)	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).