Gestational DiabetesNCT03644238
The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women
A study testing Oral Glucose Tolerance Test, Inactivity and Physical activity in people with Gestational Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the project is to investigate the acute effect of exercise on blood glucose after glucose consumption. Thereby we wish to achieve knowledge that can improve prevention and treatment of gestational overweight and gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Oral Glucose Tolerance Test, Inactivity and Physical activity
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Aug 2017to 30 Aug 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prepregnancy BMI > 27
Who cannot join
- Physical disability that affect movement
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Obstetrics and Gynecology, Aarhus University Hospital
Aarhus, 8200
About this study
The aim of the project is to investigate the acute effect of exercise on blood glucose after glucose consumption. Thereby we wish to achieve knowledge that can improve prevention and treatment of gestational overweight and gestational diabetes mellitus (GDM). This will prevent serious complications during pregnancy and birth, but also long term complications like type 2 diabetes mellitus (T2DM) for both the mother and the offspring.
15 pregnant participants will perform two Oral Glucose Tolerance Tests (OGTT). One is followed by physical activity and the other is followed by inactivity and will serve as control. Blood glucose will be monitored continuously during the study.
Read the detailed description
Cases: 15 pregnant women recruited at the routine ultrasound scan at gestational week 19 at the Department of Obstetrics and Gynecology, Aarhus University Hospital. Subjects will receive both written and oral information before entering the trial. Subjects with a prepregnancy BMI > 27 and no other risk factors of diabetes will be included in the study. The women will be examined during gestational week 27-30 where the routine Oral Glucose Tolerance Test (OGTT) will take place. The routine OGTT will serve as control.
Intervention: The subjects will perform two OGTT separated by a minimum of two days. One - the regular OGTT will serve as control and the second OGTT will be the intervention. The two days in between will function as a "wash out period" to avoid potential carry over effect. During the OGTT subjects will consume a liquid containing 75g of glucose. The control OGTT will be followed by inactivity. The intervention OGTT will be immediately followed by 20 minutes of exercise on a bicycle ergometer with a fixed intensity.
Study variables: Blood glucose will be monitored continuously using the IPro2 Continous Glucose Monitor (CGM) from Medtronic. A sensor is inserted into interstitial fluid and continuously generates an electrical current proportional to the glucose concentration. A recorder stores the average sensor current every 5 minutes.
In both control and intervention, blood tests will be taken at time 0, 1 and 2 hours after the OGTT. Blood samples will be analyzed for blood glucose, HbA1c, C-peptide and insulin.
Data on demography, family history of diabetes, prepregnancy BMI, gestational weight gain and complications during pregnancy are collected from medical records of the patients and their offspring.
- Conditions
- Gestational Diabetes
- Being tested
- Oral Glucose Tolerance Test, Inactivity, Physical activity
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance TestDiagnostic test
Also called OGTT
75g of glucose is consumed
InactivityBehavioural
Lying or sitting down.
Physical activityBehavioural
20 minutes of fixed intensity exercise on a bicycle ergometer.
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention | Experimental | Oral Glucose Tolerance Test and physical activity Receives: Diagnostic Test: Oral Glucose Tolerance Test; Behavioral: Physical activity |
| Control intervention | Other | Oral Glucose Tolerance Test and inactivity. Receives: Diagnostic Test: Oral Glucose Tolerance Test; Behavioral: Inactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Difference in blood glucose between experimental intervention and control intervention.
Measured: Through intervention periods of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start21 Aug 2017
- Primary completion27 Jul 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Ovesen, MD, Prof., Study director, Aarhus University Hospital / University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644238
- Sponsor's protocol ID
- OGTT study
- Status last verified
- May 2019
- First submitted
- 9 Apr 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen MB, Ovesen PG, Daugaard M, Ostenfeld EB, Fuglsang J. Cycling reduces blood glucose excursions after an oral glucose tolerance test in pregnant women: a randomized crossover trial. Appl Physiol Nutr Metab. 2020 Nov;45(11):1247-1252. doi: 10.1139/apnm-2020-0020. Epub 2020 May 22.
PubMed 32442384
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women
- ClinicalTrials.gov ID
- NCT03644238
- Acronym / sponsor ID
- OGTT study
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 23 Aug 2018 (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.
The aim of the project is to investigate the acute effect of exercise on blood glucose after glucose consumption. Thereby we wish to achieve knowledge that can improve prevention and treatment of gestational overweight and gestational diabetes mellitus (GDM). This will prevent serious complications during pregnancy and birth, but also long term complications like type 2 diabetes mellitus (T2DM) for both the mother and the offspring.
15 pregnant participants will perform two Oral Glucose Tolerance Tests (OGTT). One is followed by physical activity and the other is followed by inactivity and will serve as control. Blood glucose will be monitored continuously during the study.
Detailed description
Cases: 15 pregnant women recruited at the routine ultrasound scan at gestational week 19 at the Department of Obstetrics and Gynecology, Aarhus University Hospital. Subjects will receive both written and oral information before entering the trial. Subjects with a prepregnancy BMI > 27 and no other risk factors of diabetes will be included in the study. The women will be examined during gestational week 27-30 where the routine Oral Glucose Tolerance Test (OGTT) will take place. The routine OGTT will serve as control.
Intervention: The subjects will perform two OGTT separated by a minimum of two days. One - the regular OGTT will serve as control and the second OGTT will be the intervention. The two days in between will function as a "wash out period" to avoid potential carry over effect. During the OGTT subjects will consume a liquid containing 75g of glucose. The control OGTT will be followed by inactivity. The intervention OGTT will be immediately followed by 20 minutes of exercise on a bicycle ergometer with a fixed intensity.
Study variables: Blood glucose will be monitored continuously using the IPro2 Continous Glucose Monitor (CGM) from Medtronic. A sensor is inserted into interstitial fluid and continuously generates an electrical current proportional to the glucose concentration. A recorder stores the average sensor current every 5 minutes.
In both control and intervention, blood tests will be taken at time 0, 1 and 2 hours after the OGTT. Blood samples will be analyzed for blood glucose, HbA1c, C-peptide and insulin.
Data on demography, family history of diabetes, prepregnancy BMI, gestational weight gain and complications during pregnancy are collected from medical records of the patients and their offspring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention | Experimental | Diagnostic Test: Oral Glucose Tolerance Test, Behavioral: Physical activityOral Glucose Tolerance Test and physical activity |
| Control intervention | Other | Diagnostic Test: Oral Glucose Tolerance Test, Behavioral: InactivityOral Glucose Tolerance Test and inactivity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prepregnancy BMI > 27
Key exclusion criteria (1 listed)
- Physical disability that affect movement
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 |
|---|---|---|
| Oral Glucose Tolerance TestAlso: OGTT75g of glucose is consumed | Diagnostic test | Control intervention, Experimental intervention |
| InactivityLying or sitting down. | Behavioural | Control intervention |
| Physical activity20 minutes of fixed intensity exercise on a bicycle ergometer. | Behavioural | Experimental intervention |
Primary outcome
Blood glucose
Time frame: Through intervention periods of 2 hours.
Difference in blood glucose between experimental intervention and control intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Derived from this study: PubMed 32442384Andersen MB, Ovesen PG, Daugaard M, Ostenfeld EB, Fuglsang J. Cycling reduces blood glucose excursions after an oral glucose tolerance test in pregnant women: a randomized crossover trial. Appl Physiol Nutr Metab. 2020 Nov;45(11):1247-1252. doi: 10.1139/apnm-2020-0020. Epub 2020 May 22.
- 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.
Per Ovesen, MD, Prof. study director
Aarhus University Hospital / University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance Test, Inactivity and Physical activity in people with Gestational Diabetes, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2019. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: Through intervention periods of 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644238, which also lists 1 linked publication.
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 2019.