Aerobic Exercise in Women With Gestational Diabetes (GDM-FIT)
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy
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)
Sites / Locations
- Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of VeronaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Supervised exercise intervention
Current standard of care
Arm Description
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).
Women in the control group will receive standard physical exercise recommendations.
Outcomes
Primary Outcome Measures
Change in fasting plasma glucose levels (mg/dL)
Secondary Outcome Measures
Change in body weight (kg)
Change in body mass index (kg/m^2, weight in kilograms, height in meters)
Change in blood pressure (mmHg)
Change in heart rate (HR, beats per minute)
Dosage of insulin therapy, if required
Insulin units and week at start
Change in caloric intake
By 3 day-food recall questionnaire (kcal/die)
Change in energy expenditure through voluntary physical activity
Energy expenditure is estimated by International Physical Activity Questionnaire (IPAQ)
Compliance (percentage)
Attendance at the scheduled sessions is recorded for each patient
Circulating c-reactive protein (CRP) levels (mg/dL)
Adiponectin levels (μg/mL)
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
Quality of life (questionnaire)
Measured by SF-36 (36-item Short Form Health Survey-36) questionnaire
Depression state (questionnaire)
Measured by Center of Epidemiological Studies Depression Scale
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
Fetus bi-parietal diameter (cm)
Fetus head circumference (cm)
Fetus abdominal circumference (cm)
Fetus femur length (cm)
Weight (kg) of child at birth
Length (cm) of child at birth
Apgar index (score) at 1st and 5th minutes
Gender (M/F)
Malformations and neonatal diseases (YES/NO)
Type of delivery (spontaneous, induced, caesarean section)
Week of delivery (wk)
Type of feeding (breastfeeding or bottle feeding)
Weight (kg) of child 3 months after delivery
Length (cm) of child 3 months after delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03067662
Brief Title
Aerobic Exercise in Women With Gestational Diabetes
Acronym
GDM-FIT
Official Title
Efficacy of Supervised Physical Exercise in Metabolic Control of Women With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 27, 2012 (undefined)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised exercise intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Current standard of care
Arm Type
No Intervention
Arm Description
Women in the control group will receive standard physical exercise recommendations.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Primary Outcome Measure Information:
Title
Change in fasting plasma glucose levels (mg/dL)
Time Frame
Before intervention and at 35-37 week of gestation
Secondary Outcome Measure Information:
Title
Change in body weight (kg)
Time Frame
Before intervention and at 35-37 week of gestation
Title
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
Title
Change in blood pressure (mmHg)
Time Frame
Before intervention and at 35-37 week of gestation
Title
Change in heart rate (HR, beats per minute)
Time Frame
Before intervention and at 35-37 week of gestation
Title
Dosage of insulin therapy, if required
Description
Insulin units and week at start
Time Frame
Before intervention and at 35-37 week of gestation
Title
Change in caloric intake
Description
By 3 day-food recall questionnaire (kcal/die)
Time Frame
Before intervention and at 35-37 week of gestation
Title
Change in energy expenditure through voluntary physical activity
Description
Energy expenditure is estimated by International Physical Activity Questionnaire (IPAQ)
Time Frame
Before intervention and at 35-37 week of gestation
Title
Compliance (percentage)
Description
Attendance at the scheduled sessions is recorded for each patient
Time Frame
Throughout the intervention period, an average of 3-5 months according to the gestational week of inclusion in the study
Title
Circulating c-reactive protein (CRP) levels (mg/dL)
Time Frame
Before intervention and at 35-37 week of gestation
Title
Adiponectin levels (μg/mL)
Time Frame
Before intervention and at 35-37 week of gestation
Title
Pulse wave velocity (PWV, m/s)
Description
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
Time Frame
Before intervention and at 35-37 week of gestation
Title
Quality of life (questionnaire)
Description
Measured by SF-36 (36-item Short Form Health Survey-36) questionnaire
Time Frame
Before intervention and at 35-37 week of gestation
Title
Depression state (questionnaire)
Description
Measured by Center of Epidemiological Studies Depression Scale
Time Frame
Before intervention and at 35-37 week of gestation
Title
Glucose concentration during and after exercise
Description
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
Time Frame
At 32-34 week of gestation
Title
Fetus bi-parietal diameter (cm)
Time Frame
At 20, 30, 34-37 week of gestation
Title
Fetus head circumference (cm)
Time Frame
At 20, 30, 34-37 week of gestation
Title
Fetus abdominal circumference (cm)
Time Frame
At 20, 30, 34-37 week of gestation
Title
Fetus femur length (cm)
Time Frame
At 20, 30, 34-37 week of gestation
Title
Weight (kg) of child at birth
Time Frame
3 months after delivery
Title
Length (cm) of child at birth
Time Frame
3 months after delivery
Title
Apgar index (score) at 1st and 5th minutes
Time Frame
Birthday
Title
Gender (M/F)
Time Frame
3 months after delivery
Title
Malformations and neonatal diseases (YES/NO)
Time Frame
3 months after delivery
Title
Type of delivery (spontaneous, induced, caesarean section)
Time Frame
3 months after delivery
Title
Week of delivery (wk)
Time Frame
3 months after delivery
Title
Type of feeding (breastfeeding or bottle feeding)
Time Frame
3 months after delivery
Title
Weight (kg) of child 3 months after delivery
Time Frame
3 months after delivery
Title
Length (cm) of child 3 months after delivery
Time Frame
3 months after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Moghetti, MD, PhD
Email
paolo.moghetti@univr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Donà, MSC
Email
silvia.dona@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Moghetti, MD, PhD
Organizational Affiliation
University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Moghetti
Email
paolo.moghetti@univr.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Aerobic Exercise in Women With Gestational Diabetes
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