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

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ClinicalTrials.gov Identifier: NCT02229487
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : August 14, 2017
Last Update Posted : October 10, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sirimon Reutrakul, Ramathibodi Hospital

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

Condition or disease Intervention/treatment Phase
Prediabetes Other: Oral glucose tolerance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
Study Start Date : October 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
Drug Information available for: Dextrose

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229487


Locations
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Thailand
Faculty of Medicine Ramathibodi Hospital
Bangkok, Thailand
Sponsors and Collaborators
Ramathibodi Hospital
Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Sirimon Reutrakul, Ramathibodi Hospital:

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Responsible Party: Sirimon Reutrakul, Associate Professor, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT02229487     History of Changes
Other Study ID Numbers: 08-57-16
First Posted: September 1, 2014    Key Record Dates
Results First Posted: August 14, 2017
Last Update Posted: October 10, 2017
Last Verified: September 2017
Keywords provided by Sirimon Reutrakul, Ramathibodi Hospital:
Prediabetes
Short sleepers
GLP-1
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs