Clinical trial NCT03067662: Aerobic Exercise in Women With Gestational Diabetes
Official title: Efficacy of Supervised Physical Exercise in Metabolic Control of Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in fasting plasma glucose levels (mg/dL)
timeFrame: Before intervention and at 35-37 week of gestation
Secondary outcomes:
measure: Change in body weight (kg)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Change in body mass index (kg/m^2, weight in kilograms, height in meters)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Change in blood pressure (mmHg)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Change in heart rate (HR, beats per minute)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Dosage of insulin therapy, if required
timeFrame: Before intervention and at 35-37 week of gestation
measure: Change in caloric intake
timeFrame: Before intervention and at 35-37 week of gestation
measure: Change in energy expenditure through voluntary physical activity
timeFrame: Before intervention and at 35-37 week of gestation
measure: Compliance (percentage)
timeFrame: Throughout the intervention period, an average of 3-5 months according to the gestational week of inclusion in the study
measure: Circulating c-reactive protein (CRP) levels (mg/dL)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Adiponectin levels (μg/mL)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Pulse wave velocity (PWV, m/s)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Quality of life (questionnaire)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Depression state (questionnaire)
timeFrame: Before intervention and at 35-37 week of gestation
measure: Glucose concentration during and after exercise
timeFrame: At 32-34 week of gestation
measure: Fetus bi-parietal diameter (cm)
timeFrame: At 20, 30, 34-37 week of gestation
measure: Fetus head circumference (cm)
timeFrame: At 20, 30, 34-37 week of gestation
measure: Fetus abdominal circumference (cm)
timeFrame: At 20, 30, 34-37 week of gestation
measure: Fetus femur length (cm)
timeFrame: At 20, 30, 34-37 week of gestation
measure: Weight (kg) of child at birth
timeFrame: 3 months after delivery
measure: Length (cm) of child at birth
timeFrame: 3 months after delivery
measure: Apgar index (score) at 1st and 5th minutes
timeFrame: Birthday
measure: Gender (M/F)
timeFrame: 3 months after delivery
measure: Malformations and neonatal diseases (YES/NO)
timeFrame: 3 months after delivery
measure: Type of delivery (spontaneous, induced, caesarean section)
timeFrame: 3 months after delivery
measure: Week of delivery (wk)
timeFrame: 3 months after delivery
measure: Type of feeding (breastfeeding or bottle feeding)
timeFrame: 3 months after delivery
measure: Weight (kg) of child 3 months after delivery
timeFrame: 3 months after delivery
measure: Length (cm) of child 3 months after delivery
timeFrame: 3 months after delivery
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
Study officials:
affiliation: University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
name: Paolo Moghetti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: