Aerobic Exercise in Women With Gestational Diabetes

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

— GDM-FIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03067662
• Other study ID #: 2152
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2012
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2021
• Source: Universita di Verona
• Contact: Paolo Moghetti, MD, PhD
• Email: paolo.moghetti[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Other:
• Aerobic exercise

Locations

Country	Name	City	State
Italy	Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting plasma glucose levels (mg/dL)		Before intervention and at 35-37 week of gestation
Secondary	Change in body weight (kg)		Before intervention and at 35-37 week of gestation
Secondary	Change in body mass index (kg/m^2, weight in kilograms, height in meters)		Before intervention and at 35-37 week of gestation
Secondary	Change in blood pressure (mmHg)		Before intervention and at 35-37 week of gestation
Secondary	Change in heart rate (HR, beats per minute)		Before intervention and at 35-37 week of gestation
Secondary	Dosage of insulin therapy, if required	Insulin units and week at start	Before intervention and at 35-37 week of gestation
Secondary	Change in caloric intake	By 3 day-food recall questionnaire (kcal/die)	Before intervention and at 35-37 week of gestation
Secondary	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
Secondary	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
Secondary	Circulating c-reactive protein (CRP) levels (mg/dL)		Before intervention and at 35-37 week of gestation
Secondary	Adiponectin levels (µg/mL)		Before intervention and at 35-37 week of gestation
Secondary	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
Secondary	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
Secondary	Depression state (questionnaire)	Measured by Center of Epidemiological Studies Depression Scale	Before intervention and at 35-37 week of gestation
Secondary	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
Secondary	Fetus bi-parietal diameter (cm)		At 20, 30, 34-37 week of gestation
Secondary	Fetus head circumference (cm)		At 20, 30, 34-37 week of gestation
Secondary	Fetus abdominal circumference (cm)		At 20, 30, 34-37 week of gestation
Secondary	Fetus femur length (cm)		At 20, 30, 34-37 week of gestation
Secondary	Weight (kg) of child at birth		3 months after delivery
Secondary	Length (cm) of child at birth		3 months after delivery
Secondary	Apgar index (score) at 1st and 5th minutes		Birthday
Secondary	Gender (M/F)		3 months after delivery
Secondary	Malformations and neonatal diseases (YES/NO)		3 months after delivery
Secondary	Type of delivery (spontaneous, induced, caesarean section)		3 months after delivery
Secondary	Week of delivery (wk)		3 months after delivery
Secondary	Type of feeding (breastfeeding or bottle feeding)		3 months after delivery
Secondary	Weight (kg) of child 3 months after delivery		3 months after delivery
Secondary	Length (cm) of child 3 months after delivery		3 months after delivery