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CompletedNCT02229487Sleep GLP-1Updated Oct 10, 2017Results posted

The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers

An interventional study of Oral glucose tolerance in Prediabetes, sponsored by Ramathibodi Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-10.

Sponsored by Ramathibodi Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Prediabetes

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Keywords

  • Prediabetes
  • Short sleepers
  • GLP-1
03

In context

Prediabetic State

1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.

This study's enrollment of 51 is below the median of 66 across 861 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

Ramathibodi Hospital is the lead sponsor of 63 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Age 18 or older
  3. Can understand Thai (speaking, listening and reading)
  4. Agree to participate by written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Those who depend on others for feeding (such as stroke patients)
  2. Shift workers
  3. History of congestive heart failure or low ejection fraction
  4. Chronic obstructive pulmonary disease, end stage renal disease or chronic liver disease (AST or ALT > 3 times the upper limit of normal)
  5. Use of medications: opioids/ narcotics , alpha blockers (prazosin, doxazosin, terazosin), clonidine, methyldopa, nitroglycerin
  6. Patients with permanent pacemaker
  7. History of previous stroke
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Active comparator
    Normal Sleepers

    Prediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively

    Other: Oral glucose tolerance

  • Experimental
    Short Sleepers

    Prediabetes patients with short sleep duration (\<6 hours/night) as measured objectively

    Other: Oral glucose tolerance

Interventions

  • OtherOral glucose tolerance
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 weeks

07

Results

Posted Aug 14, 2017

Participant flow

Participant flow — Overall Study
MilestoneNormal SleepersShort Sleepers
Started2427
Completed2427
Not completed00

Outcome measures

PrimaryGLP-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

Time frame:
2 weeks
Reported as:
Median · pmol/l.h
GLP-1 Levels in Response to Oral Glucose Tolerance Test
pmol/l.hShort SleepersNormal Sleepers
GLP-1 Levels in Response to Oral Glucose Tolerance Test16.66 (12.21 to 21.10)18.57 (13.42 to 39.15)
Statistical analysis
  • Short Sleepers vs Normal Sleepers · Wilcoxon (Mann-Whitney) · p = 0.209

Adverse events

Collected over 18 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Normal Sleeper0/24 (0%)0/24 (0%)0/24 (0%)
Short Sleeper0/27 (0%)0/27 (0%)0/27 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Normal SleeperShort SleeperTotal
Mean55.5 ± 9.855.8 ± 6.755.7 ± 8.2
Sex: Female, Male
Sex: Female, Male(Participants)Normal SleeperShort SleeperTotal
Female192039
Male5712
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Normal SleeperShort SleeperTotal
Thai242751
Region of Enrollment
Region of Enrollment(Participants)Normal SleeperShort SleeperTotal
Thailand242751
BMI
BMI(kg/m^2)Normal SleeperShort SleeperTotal
Mean26.7 ± 3.226.8 ± 3.826.8 ± 3.5
08

Study locations

1 site
  • Faculty of Medicine Ramathibodi Hospital
    Bangkok, Thailand
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 5, 2014

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Mar 2017 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2017, 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2014
First posted
Sep 1, 2014
Start
Oct 2014
Primary completionActual
Mar 2017
CompletionActual
Mar 31, 2017
Results first posted
Aug 14, 2017
Last update
Oct 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02229487
Lead sponsor
Ramathibodi Hospital
Responsible party
Sirimon Reutrakul (Associate Professor, Ramathibodi Hospital) — Principal investigator
First posted
Sep 1, 2014
Start date
Oct 2014
Primary completion
Mar 2017
Completion
Mar 31, 2017
Results posted
Aug 14, 2017
Last update
Oct 10, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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