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Impact of Exenatide on Sleep in Type 2 Diabetes

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes; Sleep Disordered Breathing

Intervention: Exenatide (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Eve Van Cauter, PhD, Principal Investigator, Affiliation: University of Chicago

Overall contact:
Guglielmo Beccuti, MD, Phone: 773 834-5845

Summary

The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.

Clinical Details

Official title: Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

minutes of non-REM slow wave sleep

total amount of slow wave activity during sleep derived from laboratory polysomnogram

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with a diagnosis of T2DM based on physician documentation according to

established guidelines will be eligible. Exclusion Criteria:

- Patients with unstable cardiac, neurological or psychiatric disease

- Women who are pregnant or report trying to get pregnant will be excluded.

- Patients treated for obstructive sleep apnea (OSA) will be excluded.

- Patients with established OSA will be included only if they have declined treatment

of OSA.

- Patients with morbid obesity (BMI ≥ 40 gk/m2)

- Patients on insulin

- Patients already taking an incretin-based drug will not be included

- Patients with renal disease (creatinine clearance <30 ml/min), gastroparesis and

history of pancreatitis will also be excluded based on known possible adverse medication side effects.

- Patients taking an insulin secretagogue will be excluded.

- Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.

Locations and Contacts

Guglielmo Beccuti, MD, Phone: 773 834-5845

The University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Eve Van Cauter, PhD, Phone: 773-702-0169, Email: evcauter@medicine.bsd.uchicago.edu
Eve Van Cauter, PhD, Principal Investigator

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Guglielmo Beccuti, MD, Phone: 773-834-5845

Additional Information

Starting date: June 2010
Last updated: December 5, 2014

Page last updated: August 23, 2015

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