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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02229487
Date of registration: 28/08/2014
Prospective Registration: Yes
Primary sponsor: Ramathibodi Hospital
Public title: The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers Sleep GLP-1
Scientific title: The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
Date of first enrolment: October 2014
Target sample size: 51
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02229487
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Thailand
Contacts
Key inclusion & exclusion criteria

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:

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Prediabetes
Intervention(s)
Other: Oral glucose tolerance
Primary Outcome(s)
GLP-1 Levels in Response to Oral Glucose Tolerance Test [Time Frame: 2 weeks]
Secondary Outcome(s)
Secondary ID(s)
08-57-16
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Merck Sharp & Dohme Corp.
Ethics review
Results
Results available: Yes
Date Posted: 14/08/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02229487
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