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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
Verona, Italy
RECRUITINGChange in fasting plasma glucose levels (mg/dL)
Time frame: Before intervention and at 35-37 week of gestation
Change in body weight (kg)
Time frame: Before intervention and at 35-37 week of gestation
Change in body mass index (kg/m^2, weight in kilograms, height in meters)
Time frame: Before intervention and at 35-37 week of gestation
Change in blood pressure (mmHg)
Time frame: Before intervention and at 35-37 week of gestation
Change in heart rate (HR, beats per minute)
Time frame: Before intervention and at 35-37 week of gestation
Dosage of insulin therapy, if required
Insulin units and week at start
Time frame: Before intervention and at 35-37 week of gestation
Change in caloric intake
By 3 day-food recall questionnaire (kcal/die)
Time frame: 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)
Time frame: Before intervention and at 35-37 week of gestation
Compliance (percentage)
Attendance at the scheduled sessions is recorded for each patient
Time frame: 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)
Time frame: Before intervention and at 35-37 week of gestation
Adiponectin levels (μg/mL)
Time frame: 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
Time frame: 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
Time frame: Before intervention and at 35-37 week of gestation
Depression state (questionnaire)
Measured by Center of Epidemiological Studies Depression Scale
Time frame: 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
Time frame: At 32-34 week of gestation
Fetus bi-parietal diameter (cm)
Time frame: At 20, 30, 34-37 week of gestation
Fetus head circumference (cm)
Time frame: At 20, 30, 34-37 week of gestation
Fetus abdominal circumference (cm)
Time frame: At 20, 30, 34-37 week of gestation
Fetus femur length (cm)
Time frame: At 20, 30, 34-37 week of gestation
Weight (kg) of child at birth
Time frame: 3 months after delivery
Length (cm) of child at birth
Time frame: 3 months after delivery
Apgar index (score) at 1st and 5th minutes
Time frame: Birthday
Gender (M/F)
Time frame: 3 months after delivery
Malformations and neonatal diseases (YES/NO)
Time frame: 3 months after delivery
Type of delivery (spontaneous, induced, caesarean section)
Time frame: 3 months after delivery
Week of delivery (wk)
Time frame: 3 months after delivery
Type of feeding (breastfeeding or bottle feeding)
Time frame: 3 months after delivery
Weight (kg) of child 3 months after delivery
Time frame: 3 months after delivery
Length (cm) of child 3 months after delivery
Time frame: 3 months after delivery
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