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

NCT ID: NCT02229487

Last Updated: 2017-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Prediabetes

Keywords

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Prediabetes Short sleepers GLP-1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Normal Sleepers

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

Group Type ACTIVE_COMPARATOR

Oral glucose tolerance

Intervention Type OTHER

Short Sleepers

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

Group Type EXPERIMENTAL

Oral glucose tolerance

Intervention Type OTHER

Interventions

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Oral glucose tolerance

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sirimon Reutrakul

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Ramathibodi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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08-57-16

Identifier Type: -

Identifier Source: org_study_id