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

Prediabetes Clinical Trial

— Sleep GLP-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229487
• Other study ID #: 08-57-16
• Status: Completed
• Phase: N/A
• First received: August 28, 2014
• Last updated: September 11, 2017
• Start date: October 2014
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2017
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 31, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Other:
• Oral glucose tolerance

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Ramathibodi Hospital	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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