Gestational Diabetes MellitusNCT01748305
Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus
A study testing Moderate-to-vigorous intensity exercise in people with Gestational Diabetes Mellitus and Exercise, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to… 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 Mellitus, Exercise
- What is being tested?
- Moderate-to-vigorous intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2013
- 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
- gestational diabetes mellitus
- singelton pregnancy
- 18 years old or older
- no medical contraindications to exercise
Who cannot join
- multiple gestation
- non-English speaking
- unable to exercise
- preexisting diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study
Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. All participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. The hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.
- Conditions
- Gestational Diabetes Mellitus, Exercise
- Being tested
- Moderate-to-vigorous intensity exercise
- Keywords
- GDM, A1GDM, A2GDM
- Medical subject headings
- Diabetes, Gestational, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-to-vigorous intensity exerciseBehavioural
Moderate-to-vigorous intensity exercise three times per day for three weeks
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-vigorous intensity exercise | Experimental | Moderate-to-vigorous intensity exercise three times per day for three weeks Receives: Behavioral: Moderate-to-vigorous intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for medication for diabetes
Measured: 3 weeks
Secondary outcomes (3)
Birth weight
Measured: delivery
A1c
Measured: delivery
Mode of delivery
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Recruitment issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio E. Frias, Oregon Health and Science University
- Investigators
- Antonio Frias, MD, Principal investigator, Oregon Health and Science UniversityJessica Voge, MD, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748305
- Sponsor's protocol ID
- e8631
- Status last verified
- Oct 2015
- First submitted
- 10 Dec 2012
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study
- ClinicalTrials.gov ID
- NCT01748305
- Acronym / sponsor ID
- e8631
- Conditions
- Gestational Diabetes Mellitus, Exercise
- Keywords
- GDM, A1GDM, A2GDM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Dec 2012 (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.
Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. All participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. The hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-vigorous intensity exercise | Experimental | Behavioral: Moderate-to-vigorous intensity exerciseModerate-to-vigorous intensity exercise three times per day for three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- gestational diabetes mellitus
- singelton pregnancy
- 18 years old or older
- no medical contraindications to exercise
Key exclusion criteria (4 listed)
- multiple gestation
- non-English speaking
- unable to exercise
- preexisting diabetes
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 |
|---|---|---|
| Moderate-to-vigorous intensity exerciseModerate-to-vigorous intensity exercise three times per day for three weeks | Behavioural | Moderate-to-vigorous intensity exercise |
Primary outcome
Need for medication for diabetes
Time frame: 3 weeks
3 secondary outcomes
Birth weight
Time frame: delivery
A1c
Time frame: delivery
Mode of delivery
Time frame: delivery
Results and safety
The study was stopped early (reason given: Recruitment issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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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.
Antonio Frias, MD principal investigator
Oregon Health and Science University
Jessica Voge, MD study director
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-to-vigorous intensity exercise in people with Gestational Diabetes Mellitus and Exercise, run by Oregon Health and Science University at 1 site in United States.
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 4 inclusion and 4 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 23 Oct 2015. 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 United States. 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: Recruitment issues.). 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?
Need for medication for diabetes (time frame: 3 weeks). 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 23 Oct 2015.