Gestational Diabetes Mellitus in PregnancyGDM-FITNCT03067662
Aerobic Exercise in Women With Gestational Diabetes
A study testing Aerobic exercise in people with Gestational Diabetes Mellitus in Pregnancy, run by Universita di Verona at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2012to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy,
- Gestational diabetes diagnosis between 18th and 28th week of gestation,
- Caucasian.
Who cannot join
- Hemodynamically significant heart disease,
- Restricted lung disease,
- Incompetent cervix/cerclage,
- Persistent second or third trimester bleeding,
- Placenta previa,
- Threatened preterm labor,
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Paolo Moghetti, MD, PhD contact
Silvia Donà, MSC contact
Italy1 site, 1 recruiting
- Recruiting
Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
Verona, 37126
Paolo Moghetti, paolo.moghetti@univr.it
About this study
Official title: 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.
Read more
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.
- Being tested
- Aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Aerobic exercise |
| Current standard of care | No intervention | Women in the control group will receive standard physical exercise recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting plasma glucose levels (mg/dL)
Measured: Before intervention and at 35-37 week of gestation
Secondary outcomes (28)
Change in body weight (kg)
Measured: Before intervention and at 35-37 week of gestation
Change in body mass index (kg/m^2, weight in kilograms, height in meters)
Measured: Before intervention and at 35-37 week of gestation
Change in blood pressure (mmHg)
Measured: Before intervention and at 35-37 week of gestation
Change in heart rate (HR, beats per minute)
Measured: Before intervention and at 35-37 week of gestation
Dosage of insulin therapy, if required
Insulin units and week at start
Measured: Before intervention and at 35-37 week of gestation
Change in caloric intake
By 3 day-food recall questionnaire (kcal/die)
Measured: 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)
Measured: Before intervention and at 35-37 week of gestation
Compliance (percentage)
Attendance at the scheduled sessions is recorded for each patient
Measured: 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)
Measured: Before intervention and at 35-37 week of gestation
Adiponectin levels (μg/mL)
Measured: 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
Measured: 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
Measured: Before intervention and at 35-37 week of gestation
Depression state (questionnaire)
Measured by Center of Epidemiological Studies Depression Scale
Measured: 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
Measured: At 32-34 week of gestation
Fetus bi-parietal diameter (cm)
Measured: At 20, 30, 34-37 week of gestation
Fetus head circumference (cm)
Measured: At 20, 30, 34-37 week of gestation
Fetus abdominal circumference (cm)
Measured: At 20, 30, 34-37 week of gestation
Fetus femur length (cm)
Measured: At 20, 30, 34-37 week of gestation
Weight (kg) of child at birth
Measured: 3 months after delivery
Length (cm) of child at birth
Measured: 3 months after delivery
Apgar index (score) at 1st and 5th minutes
Measured: Birthday
Gender (M/F)
Measured: 3 months after delivery
Malformations and neonatal diseases (YES/NO)
Measured: 3 months after delivery
Type of delivery (spontaneous, induced, caesarean section)
Measured: 3 months after delivery
Week of delivery (wk)
Measured: 3 months after delivery
Type of feeding (breastfeeding or bottle feeding)
Measured: 3 months after delivery
Weight (kg) of child 3 months after delivery
Measured: 3 months after delivery
Length (cm) of child 3 months after delivery
Measured: 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start27 Sep 2012
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Moghetti, Universita di Verona
- Investigators
- Paolo Moghetti, MD, PhD, Principal investigator, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067662
- Sponsor's protocol ID
- 2152
- Acronym
- GDM-FIT
- Status last verified
- May 2021
- First submitted
- 3 Feb 2017
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Supervised Physical Exercise in Metabolic Control of Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03067662
- Acronym / sponsor ID
- GDM-FIT / 2152
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 27 Sep 2012
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise intervention | Experimental | Other: Aerobic exerciseWomen 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). |
| Current standard of care | No intervention | –Women in the control group will receive standard physical exercise recommendations. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy,
- Gestational diabetes diagnosis between 18th and 28th week of gestation,
- Caucasian.
Key exclusion criteria (17 listed)
- Hemodynamically significant heart disease,
- Restricted lung disease,
- Incompetent cervix/cerclage,
- Persistent second or third trimester bleeding,
- Placenta previa,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise | Other | Supervised exercise intervention |
Primary outcome
Change in fasting plasma glucose levels (mg/dL)
Time frame: Before intervention and at 35-37 week of gestation
28 secondary outcomes
Change in body weight (kg)
Time frame: Before intervention and at 35-37 week of gestation
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
Change in blood pressure (mmHg)
Time frame: Before intervention and at 35-37 week of gestation
Change in heart rate (HR, beats per minute)
Time frame: Before intervention and at 35-37 week of gestation
Dosage of insulin therapy, if required
Time frame: Before intervention and at 35-37 week of gestation
Change in caloric intake
Time frame: Before intervention and at 35-37 week of gestation
Change in energy expenditure through voluntary physical activity
Time frame: Before intervention and at 35-37 week of gestation
Compliance (percentage)
Time frame: 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)
Time frame: Before intervention and at 35-37 week of gestation
Adiponectin levels (μg/mL)
Time frame: Before intervention and at 35-37 week of gestation
Pulse wave velocity (PWV, m/s)
Time frame: Before intervention and at 35-37 week of gestation
Quality of life (questionnaire)
Time frame: Before intervention and at 35-37 week of gestation
Depression state (questionnaire)
Time frame: Before intervention and at 35-37 week of gestation
Glucose concentration during and after exercise
Time frame: At 32-34 week of gestation
Fetus bi-parietal diameter (cm)
Time frame: At 20, 30, 34-37 week of gestation
Fetus head circumference (cm)
Time frame: At 20, 30, 34-37 week of gestation
Fetus abdominal circumference (cm)
Time frame: At 20, 30, 34-37 week of gestation
Fetus femur length (cm)
Time frame: At 20, 30, 34-37 week of gestation
Weight (kg) of child at birth
Time frame: 3 months after delivery
Length (cm) of child at birth
Time frame: 3 months after delivery
Apgar index (score) at 1st and 5th minutes
Time frame: Birthday
Gender (M/F)
Time frame: 3 months after delivery
Malformations and neonatal diseases (YES/NO)
Time frame: 3 months after delivery
Type of delivery (spontaneous, induced, caesarean section)
Time frame: 3 months after delivery
Week of delivery (wk)
Time frame: 3 months after delivery
Type of feeding (breastfeeding or bottle feeding)
Time frame: 3 months after delivery
Weight (kg) of child 3 months after delivery
Time frame: 3 months after delivery
Length (cm) of child 3 months after delivery
Time frame: 3 months after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Moghetti, MD, PhD contact
Silvia Donà, MSC contact
Paolo Moghetti, MD, PhD principal investigator
University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Gestational Diabetes Mellitus in Pregnancy, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Moghetti, MD, PhD (paolo.moghetti@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting plasma glucose levels (mg/dL) (time frame: Before intervention and at 35-37 week of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.