Gestational DiabetesNCT02108197
Sleep Apnea and Gestational Diabetes
A study testing Continuous positive airway pressure (S9, ResMed) in people with Gestational Diabetes and Sleep Apnea, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
The investigators hypothesize that pregnant women with gestational diabetes will have a high incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose control in these women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes, Sleep Apnea
- What is being tested?
- Continuous positive airway pressure (S9, ResMed)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2014to 31 Dec 2016
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- gestational diabetes
Who cannot join
- pre-gestational diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstructive Sleep Apnea and Gestational Diabetes : Incidence and Effects of Continuous Positive Airway Pressure Treatment on Glucose Metabolism
The investigators hypothesize that pregnant women with gestational diabetes will have a high incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose control in these women.
- Conditions
- Gestational Diabetes, Sleep Apnea
- Being tested
- Continuous positive airway pressure (S9, ResMed)
- Medical subject headings
- Diabetes, Gestational, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (S9, ResMed)Device
| Study group | Role | What they receive |
|---|---|---|
| CPAP Intervention | Experimental | Continuous positive airway pressure (S9, ResMed) Receives: Device: Continuous positive airway pressure (S9, ResMed) |
| Wait-list | No intervention | Wait list controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose tolerance
Measuring glucose, fructosamine and insulin levels following a mixed meal test at 0 and 2 weeks. Glucose and insulin will be measured at 0 minutes and every 30 minutes thereafter for 2 hours. Fructosamine will be measured at 0 minutes only.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirimon Reutrakul, Ramathibodi Hospital
- Investigators
- Sirimon Reutrakul, MD, Principal investigator, Faculty of Medicine Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108197
- Sponsor's protocol ID
- 11-56-39
- Status last verified
- Jan 2018
- First submitted
- 17 Mar 2014
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Chirakalwasan N, Amnakkittikul S, Wanitcharoenkul E, Charoensri S, Saetung S, Chanprasertyothin S, Chailurkit LO, Panburana P, Bumrungphuet S, Thakkinstian A, Reutrakul S. Continuous Positive Airway Pressure Therapy in Gestational Diabetes With Obstructive Sleep Apnea: A Randomized Controlled Trial. J Clin Sleep Med. 2018 Mar 15;14(3):327-336. doi: 10.5664/jcsm.6972.
PubMed 29458699
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea and Gestational Diabetes : Incidence and Effects of Continuous Positive Airway Pressure Treatment on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT02108197
- Acronym / sponsor ID
- 11-56-39
- Conditions
- Gestational Diabetes, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 9 Apr 2014 (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.
The investigators hypothesize that pregnant women with gestational diabetes will have a high incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose control in these women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP Intervention | Experimental | Device: Continuous positive airway pressure (S9, ResMed)Continuous positive airway pressure (S9, ResMed) |
| Wait-list | No intervention | –Wait list controls |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- gestational diabetes
Key exclusion criteria (1 listed)
- pre-gestational 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 |
|---|---|---|
| Continuous positive airway pressure (S9, ResMed) | Device | CPAP Intervention |
Primary outcome
glucose tolerance
Time frame: two weeks
Measuring glucose, fructosamine and insulin levels following a mixed meal test at 0 and 2 weeks. Glucose and insulin will be measured at 0 minutes and every 30 minutes thereafter for 2 hours. Fructosamine will be measured at 0 minutes only.
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 19 Jan 2018.
- Derived from this study: PubMed 29458699Chirakalwasan N, Amnakkittikul S, Wanitcharoenkul E, Charoensri S, Saetung S, Chanprasertyothin S, Chailurkit LO, Panburana P, Bumrungphuet S, Thakkinstian A, Reutrakul S. Continuous Positive Airway Pressure Therapy in Gestational Diabetes With Obstructive Sleep Apnea: A Randomized Controlled Trial. J Clin Sleep Med. 2018 Mar 15;14(3):327-336. doi: 10.5664/jcsm.6972.
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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.
Sirimon Reutrakul, MD principal investigator
Faculty of Medicine Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure (S9, ResMed) in people with Gestational Diabetes and Sleep Apnea, run by Ramathibodi Hospital at 1 site in Thailand.
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 19 Jan 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 Thailand. 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?
glucose tolerance (time frame: two weeks). 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 NCT02108197, 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 19 Jan 2018.