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

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Oral glucose tolerance
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prediabetes focused on measuring Prediabetes, Short sleepers, GLP-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal Sleepers

Short Sleepers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 28, 2014
Last Updated
September 11, 2017
Sponsor
Ramathibodi Hospital
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02229487
Brief Title
The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
Acronym
Sleep GLP-1
Official Title
The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothesis Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
Prediabetes, Short sleepers, GLP-1

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Sleepers
Arm Type
Active Comparator
Arm Description
Prediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively
Arm Title
Short Sleepers
Arm Type
Experimental
Arm Description
Prediabetes patients with short sleep duration (<6 hours/night) as measured objectively
Intervention Type
Other
Intervention Name(s)
Oral glucose tolerance
Primary Outcome Measure Information:
Title
GLP-1 Levels in Response to Oral Glucose Tolerance Test
Description
Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine Ramathibodi Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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