Aerobic Exercise in Women With Gestational Diabetes

NCT ID: NCT03067662

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-27
• Study Completion Date: 2022-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: OTHER

Current standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic exercise

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Paolo Moghetti

Associate Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Moghetti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona

Locations

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

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Moghetti, MD, PhD

Role: CONTACT

paolo.moghetti@univr.it

Silvia Donà, MSC

Role: CONTACT

silvia.dona@univr.it

Facility Contacts

Paolo Moghetti

Role: primary

paolo.moghetti@univr.it

Other Identifiers

2152

Identifier Type: -

Identifier Source: org_study_id