Clinical Trial: Aerobic Exercise in Women With Gestational Diabetes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Universita di Verona

Current Primary Outcome: Change in fasting plasma glucose levels (mg/dL) [ Time Frame: Before intervention and at 35-37 week of gestation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: Before intervention and at 35-37 week of gestation ]
    Insulin units and week at start
  • Change in caloric intake [ Time Frame: Before intervention and at 35-37 week of gestation ]
    By 3 day-food recall questionnaire (kcal/die)
  • Change in energy expenditure through voluntary physical activity [ Time Frame: Before intervention and at 35-37 week of gestation ]
    Energy expenditure is estimated by International Physical Activity Questionnaire (IPAQ)
  • Compliance (percentage) [ Time Frame: Throughout the intervention period, an average of 3-5 months according to the gestational week of inclusion in the study ]
    Attendance at the scheduled sessions is recorded for each patient
  • 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) [ Time Frame: Before intervention and at 35-37 week of gestation ]
    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
  • Quality of life (questionnaire) [ Time Frame: Before intervention and at 35-37 week of gestation ]
    Measured by SF-36 (36-item Short Form Health Survey-36) questionnaire
  • Depression state (questionnaire) [ Time Frame: Before intervention and at 35-37 week of gestation ]
    Measured by Center of Epidemiological Studies Depression Scale
  • Glucose concentration during and after exercise [ Time Frame: At 32-34 week of gestation ]
    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
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Universita di Verona

Dates:
Date Received: February 3, 2017
Date Started: September 27, 2012
Date Completion: December 30, 2018
Last Updated: February 23, 2017
Last Verified: February 2017