Aerobic Exercise in Women With Gestational Diabetes

NCT03067662 | Unknown DMC

• 1 other identifier: 2152
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in fasting plasma glucose levels (mg/dL)

  Before intervention and at 35-37 week of gestation

Secondary Outcomes (28)

• 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

  Before intervention and at 35-37 week of gestation

Study Arms (2)

Supervised exercise intervention

EXPERIMENTAL

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

Current standard of care

NO INTERVENTION

Women in the control group will receive standard physical exercise recommendations.

Interventions

Aerobic exercise OTHER

Supervised exercise intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy,
• Gestational diabetes diagnosis between 18th and 28th week of gestation,
• Caucasian.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona

Verona, 37126, Italy

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paolo Moghetti, MD, PhD

  University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Moghetti, MD, PhD

CONTACT

paolo.moghetti@univr.it

Silvia Donà, MSC

CONTACT

silvia.dona@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: March 1, 2017
• Study Start: September 27, 2012
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)