PrediabetesSleep GLP-1NCT02229487
The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
A study testing Oral glucose tolerance in people with Prediabetes, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
Hypothesis 1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration. 2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- Oral glucose tolerance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2014to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with prediabetes (HbA1c 5.7-6.4% or history of fasting plasma glucose 100-125 mg/dl) who receive medical care at Ramathibodi Hospital
- Age 18 or older
- Can understand Thai (speaking, listening and reading)
- Agree to participate by written informed consent
Who cannot join
- Those who depend on others for feeding (such as stroke patients)
- Shift workers
- History of congestive heart failure or low ejection fraction
- Chronic obstructive pulmonary disease, end stage renal disease or chronic liver disease (AST or ALT > 3 times the upper limit of normal)
- Use of medications: opioids/ narcotics , alpha blockers (prazosin, doxazosin, terazosin), clonidine, methyldopa, nitroglycerin
- Patients with permanent pacemaker
- History of previous stroke
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis
- Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration.
- Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal
- Conditions
- Prediabetes
- Being tested
- Oral glucose tolerance
- Keywords
- Prediabetes, Short sleepers, GLP-1
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose toleranceOther
| Study group | Role | What they receive |
|---|---|---|
| Normal Sleepers | Active comparator | Prediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively Receives: Other: Oral glucose tolerance |
| Short Sleepers | Experimental | Prediabetes patients with short sleep duration (<6 hours/night) as measured objectively Receives: Other: Oral glucose tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 Levels in Response to Oral Glucose Tolerance Test
Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PrediabetesStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Sirimon Reutrakul, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229487
- Sponsor's protocol ID
- 08-57-16
- Acronym
- Sleep GLP-1
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2014
- Last updated
- 10 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
- ClinicalTrials.gov ID
- NCT02229487
- Acronym / sponsor ID
- Sleep GLP-1 / 08-57-16
- Conditions
- Prediabetes
- Keywords
- Prediabetes, Short sleepers, GLP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Posted 14 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis
- Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration.
- Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Sleepers | Active comparator | Other: Oral glucose tolerancePrediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively |
| Short Sleepers | Experimental | Other: Oral glucose tolerancePrediabetes patients with short sleep duration (<6 hours/night) as measured objectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with prediabetes (HbA1c 5.7-6.4% or history of fasting plasma glucose 100-125 mg/dl) who receive medical care at Ramathibodi Hospital
- Age 18 or older
- Can understand Thai (speaking, listening and reading)
- Agree to participate by written informed consent
Key exclusion criteria (7 listed)
- Those who depend on others for feeding (such as stroke patients)
- Shift workers
- History of congestive heart failure or low ejection fraction
- Chronic obstructive pulmonary disease, end stage renal disease or chronic liver disease (AST or ALT > 3 times the upper limit of normal)
- Use of medications: opioids/ narcotics , alpha blockers (prazosin, doxazosin, terazosin), clonidine, methyldopa, nitroglycerin
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 | Other | Normal Sleepers, Short Sleepers |
Primary outcome
GLP-1 Levels in Response to Oral Glucose Tolerance Test
Time frame: 2 weeks
Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Prediabetes, 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 4 inclusion and 7 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 10 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
GLP-1 Levels in Response to Oral Glucose Tolerance Test (time frame: 2 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 10 Oct 2017.