Gestational Diabetes Clinical Trial
Official title:
Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes
Verified date | June 2017 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
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). |
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