Diabetes, GestationalGDMakuttNCT01961401
Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Gestational Diabetes Mellitus
A study testing exercise in people with Diabetes, Gestational, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Exercise training is recognized as effective in preventing and treating many chronic metabolic disorders (1), and long-term exercise programmes have similar effects on glucose control as long-term drug or insulin therapy in type 2 diabetic patients (2). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Feb 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant
- Gestational diabetes mellitus or normal glucose tolerance
- able to exercise
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Pregnant Women With and Without Gestational Diabetes Mellitus
Exercise training is recognized as effective in preventing and treating many chronic metabolic disorders (1), and long-term exercise programmes have similar effects on glucose control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise intensity and volume of aerobic exercise needed to produce the most wanted effects on targeted risk factors for subjects at risk of/with established type 2 diabetes, is still uncertain. In this study the investigators will investigate the acute effects of a single bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with and without gestational diabetes mellitus (GDM). The investigators think that very short bouts of high intensity exercise can be a way to reduce blood glucose in these women.
- Conditions
- Diabetes, Gestational
- Being tested
- exercise
- Keywords
- exercise, exercise therapy, insulin resistance
- Medical subject headings
- Diabetes, Gestational, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise | Experimental | High intensity, short duration exercise on bike Receives: Behavioral: exercise |
| Moderate exercise | Experimental | Moderate intensity exercise training on bike Receives: Behavioral: exercise |
| No exercise | No intervention | No exercise, resting in the lab |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
insulin sensitivity index, as described by Matsuda and DeFronzo. This calculation uses the fasting plasma glucose and plasma insulin, and the average plasma glucose and insulin values over the 30, 60, 90, and 120 minutes after an oral glucose tolerance test (OGTT), and is calculated as:. 10 000/√[fasting glucose x fasting insulin) x (mean glucose during OGTT x mean insulin during OGTT)]. We will use a carbohydrate rich meal instead of a classic oral glucose tolerance test with glucose in water.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Due to recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- trine Moholdt, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961401
- Sponsor's protocol ID
- 2012/1021
- Acronym
- GDMakutt
- Status last verified
- Apr 2018
- First submitted
- 9 Oct 2013
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Pregnant Women With and Without Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01961401
- Acronym / sponsor ID
- GDMakutt / 2012/1021
- Conditions
- Diabetes, Gestational
- Keywords
- exercise, exercise therapy, insulin resistance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment problems
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Jan 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 11 Oct 2013 (estimated)
- 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.
Exercise training is recognized as effective in preventing and treating many chronic metabolic disorders (1), and long-term exercise programmes have similar effects on glucose control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise intensity and volume of aerobic exercise needed to produce the most wanted effects on targeted risk factors for subjects at risk of/with established type 2 diabetes, is still uncertain. In this study the investigators will investigate the acute effects of a single bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with and without gestational diabetes mellitus (GDM). The investigators think that very short bouts of high intensity exercise can be a way to reduce blood glucose in these women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise | Experimental | Behavioral: exerciseHigh intensity, short duration exercise on bike |
| Moderate exercise | Experimental | Behavioral: exerciseModerate intensity exercise training on bike |
| No exercise | No intervention | –No exercise, resting in the lab |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant
- Gestational diabetes mellitus or normal glucose tolerance
- able to exercise
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| exercise | Behavioural | High intensity exercise, Moderate exercise |
Primary outcome
insulin sensitivity
Time frame: 1 day
insulin sensitivity index, as described by Matsuda and DeFronzo. This calculation uses the fasting plasma glucose and plasma insulin, and the average plasma glucose and insulin values over the 30, 60, 90, and 120 minutes after an oral glucose tolerance test (OGTT), and is calculated as:. 10 000/√[fasting glucose x fasting insulin) x (mean glucose during OGTT x mean insulin during OGTT)]. We will use a carbohydrate rich meal instead of a classic oral glucose tolerance test with glucose in water.
Results and safety
The study was stopped early (reason given: Due to recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
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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.
trine Moholdt, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Diabetes, Gestational, run by Norwegian University of Science and Technology at 1 site in Norway.
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 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: stopped early, as of the sponsor's last update on 9 Apr 2018. 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 Norway. 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 was stopped early (reason given: Due to recruitment problems). Results are not available in the source record.
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?
insulin sensitivity (time frame: 1 day). 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 9 Apr 2018.