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

NCT02229487 | Completed Results

• 1 other identifier: 08-57-16
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis

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

Conditions

Prediabetes

Keywords

Prediabetes; Short sleepers; GLP-1

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Study Arms (2)

Normal Sleepers

ACTIVE COMPARATOR

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

Other: Oral glucose tolerance

Short Sleepers

EXPERIMENTAL

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

Other: Oral glucose tolerance

Interventions

Oral glucose tolerance OTHER

Normal Sleepers; Short Sleepers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Results Point of Contact

• Title: Sirimon Reutrakul
• Organization: Ramathibodii Hospital, Mahidol University

sreutrakul@yahoo.com

66922011647

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 31, 2017
• Last Updated: October 10, 2017
• Results First Posted: August 14, 2017

Record last verified: 2017-09

Locations

TH (1)