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

September 11, 2017 updated by: Sirimon Reutrakul, Ramathibodi Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Faculty of Medicine Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Actual)

October 10, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-57-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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