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Clinical Trials/NCT02229487
NCT02229487CompletedNot Applicable

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

Ramathibodi Hospital1 site in 1 country51 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
51
Locations
1
Primary Endpoint
GLP-1 Levels in Response to Oral Glucose Tolerance Test

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Normal Sleepers

Active Comparator

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

Intervention: Oral glucose tolerance (Other)

Short Sleepers

Experimental

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

Intervention: Oral glucose tolerance (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sirimon Reutrakul

Associate Professor

Ramathibodi Hospital

Study Sites (1)

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