Aerobic Exercise in Women With Gestational Diabetes

Study Overview
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Brief Summary
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A few, small randomized controlled trials have investigated the effects of exercise on blood glucose levels in women with gestational diabetes (GDM), with inconsistent results. To assess the effects of supervised exercise in women with GDM, 48 women with gestational diabetes, diagnosed between the 18th and 28th week of gestation, will be recruited, after exclusion of subjects with contraindications to exercise. These subjects will be randomly assigned to two groups: structured exercise intervention or standard care. Women in the intervention group will perform low intensity aerobic exercise three times per week at 30% HRR (heart rate reserve), under continuous heart rate monitoring. Duration of each session will progress from 26 minutes the first week to 40 minutes (increasing 2 min/week). Women in the control group will receive standard diet and physical exercise recommendations. In all women, clinical, metabolic and anthropometric features will be assessed before, during and at the end of the study. Newborn data will also be collected.

Official Title
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Efficacy of Supervised Physical Exercise in Metabolic Control of Women With Gestational Diabetes

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Other: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy, Gestational diabetes diagnosis between 18th and 28th week of gestation, Caucasian. Exclusion Criteria: Hemodynamically significant heart disease, Restricted lung disease, Incompetent cervix/cerclage, Persistent second or third trimester bleeding, Placenta previa, Threatened preterm labor, Ruptured membranes, Preeclampsia, Hypertension, Severe anemia, Cardiac arrhythmias, History of epilepsy, Chronic bronchitis, Orthopedic limitations, Overt hyperthyroidism/ hypothyroidism, Type 1 diabetes mellitus, Drugs that interfere with metabolic control (such as cortisone)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised exercise intervention<br>Women in the intervention group will perform low intensity aerobic exercise three times per week at 30% HRR (Heart Rate Reserve), under continuous heart rate monitoring. Duration of each session will progress from 26 minutes the first week to 40 minutes (by increasing 2 min/week). | Other: Aerobic exercise<br> <br> |
| No Intervention: Current standard of care<br>Women in the control group will receive standard physical exercise recommendations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma glucose levels (mg/dL) |  | Before intervention and at 35-37 week of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight (kg) |  | Before intervention and at 35-37 week of gestation | 
| Change in body mass index (kg/m^2, weight in kilograms, height in meters) |  | Before intervention and at 35-37 week of gestation | 
| Change in blood pressure (mmHg) |  | Before intervention and at 35-37 week of gestation | 
| Change in heart rate (HR, beats per minute) |  | Before intervention and at 35-37 week of gestation | 
| Dosage of insulin therapy, if required | Insulin units and week at start | Before intervention and at 35-37 week of gestation | 
| Change in caloric intake | By 3 day-food recall questionnaire (kcal/die) | Before intervention and at 35-37 week of gestation | 
| Change in energy expenditure through voluntary physical activity | Energy expenditure is estimated by International Physical Activity Questionnaire (IPAQ) | Before intervention and at 35-37 week of gestation | 
| Compliance (percentage) | Attendance at the scheduled sessions is recorded for each patient | Throughout the intervention period, an average of 3-5 months according to the gestational week of inclusion in the study | 
| Circulating c-reactive protein (CRP) levels (mg/dL) |  | Before intervention and at 35-37 week of gestation | 
| Adiponectin levels (μg/mL) |  | Before intervention and at 35-37 week of gestation | 
| Pulse wave velocity (PWV, m/s) | A non-invasive assessment of arterial stiffness (in the carotid-radial and carotid-femoral parts of the arterial tree) by the technique of applanation tonometry | Before intervention and at 35-37 week of gestation | 
| Quality of life (questionnaire) | Measured by SF-36 (36-item Short Form Health Survey-36) questionnaire | Before intervention and at 35-37 week of gestation | 
| Depression state (questionnaire) | Measured by Center of Epidemiological Studies Depression Scale | Before intervention and at 35-37 week of gestation | 
| Glucose concentration during and after exercise | A continuous glucose monitoring system (CGMS) will be applied at 32-34 week of gestation, and blood glucose will be recorded every 5 min over the following five days. Glucose concentrations during the 40-min exercise session, the subsequent night, and the 24-h period following exercise, as well as during the corresponding periods of a non-exercise day will be recorded, and glucose variability and time spent in hypoglycemia or hyperglycemia will be calculated | At 32-34 week of gestation | 
| Fetus bi-parietal diameter (cm) |  | At 20, 30, 34-37 week of gestation | 
| Fetus head circumference (cm) |  | At 20, 30, 34-37 week of gestation | 
| Fetus abdominal circumference (cm) |  | At 20, 30, 34-37 week of gestation | 
| Fetus femur length (cm) |  | At 20, 30, 34-37 week of gestation | 
| Weight (kg) of child at birth |  | 3 months after delivery | 
| Length (cm) of child at birth |  | 3 months after delivery | 
| Apgar index (score) at 1st and 5th minutes |  | Birthday | 
| Gender (M/F) |  | 3 months after delivery | 
| Malformations and neonatal diseases (YES/NO) |  | 3 months after delivery | 
| Type of delivery (spontaneous, induced, caesarean section) |  | 3 months after delivery | 
| Week of delivery (wk) |  | 3 months after delivery | 
| Type of feeding (breastfeeding or bottle feeding) |  | 3 months after delivery | 
| Weight (kg) of child 3 months after delivery |  | 3 months after delivery | 
| Length (cm) of child 3 months after delivery |  | 3 months after delivery |