Aerobic Exercise in Women With Gestational Diabetes (GDM-FIT)

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

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 Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: Aerobic exercise

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Moghetti, MD, PhD; Email: paolo.moghetti@univr.it
• Study Contact Backup: Name: Silvia Donà, MSC; Email: silvia.dona@univr.it

Study Locations

• Italy
  • Verona, Italy, 37126
    • Recruiting
    • Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Supervised exercise intervention; 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
NO_INTERVENTION: Current standard of care; Women in the control group will receive standard physical exercise recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Paolo Moghetti, MD, PhD, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona

Study record dates

Study Major Dates

• Study Start: September 27, 2012
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (ACTUAL): March 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 2152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No