Trial Outcomes & Findings for The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers (NCT NCT02229487)
NCT ID: NCT02229487
Last Updated: 2017-10-10
Results Overview
Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
2 weeks
Results posted on
2017-10-10
Participant Flow
Participant milestones
| Measure |
Normal Sleepers
Prediabetes patients with normal sleep duration (\>=6.5 hours/ night) as measured objectively
Oral glucose tolerance
|
Short Sleepers
Prediabetes patients with short sleep duration (=\<5.75 hours/night) as measured objectively
Oral glucose tolerance
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
24
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
Baseline characteristics by cohort
| Measure |
Normal Sleeper
n=24 Participants
Sleep duration as measured by actigraphy \>=6.5 h/night
|
Short Sleeper
n=27 Participants
Sleep duration as measured by actigraphy =\<5.75 h/night
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Thai
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
BMI
|
26.7 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 3.8 • n=7 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPrediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels
Outcome measures
| Measure |
Short Sleepers
n=27 Participants
Sleep duration as measured by actigraphy =\<5.75 h/night
|
Normal Sleepers
n=24 Participants
Sleep duration as measured by actigraphy \>=6.5h/night
|
|---|---|---|
|
GLP-1 Levels in Response to Oral Glucose Tolerance Test
|
16.66 pmol/l.h
Interval 12.21 to 21.1
|
18.57 pmol/l.h
Interval 13.42 to 39.15
|
Adverse Events
Normal Sleeper
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Short Sleeper
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sirimon Reutrakul
Ramathibodii Hospital, Mahidol University
Phone: 66922011647
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place