Impact of Exenatide on Sleep Duration

NCT01416649 | Completed

• 1 other identifier: 10-051-A
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of exenatide, a FDA approved medication for the treatment of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be studied before and during treatment with Exenatide. Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient visits over the course of 3-4 months.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Sleep duration and sleep efficiency

  Sleep duration and efficiency will be measured using an activity monitor worn on the wrist.

  at the end of 3 months of treatment with the medication

Interventions

Exenatide DRUG

Exenatide is started for the treatment of type 2 diabetes as determined by the patients regular physician. The dose will be 5-10 micrograms twice daily which is the standard dose. The medication is given by self-administered subcutaneous injection. The medication may continue for the treatment of the type 2 diabetes after the study is completed after 3 months.

Also known as: The brand name of exenatide is Byetta.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Convenience Sample

You may qualify if:

• Patients taking diabetes medications other then insulin will be included, but changes to their medications may be made as deemed necessary by their physician. Patients on stable medications for chronic and co-morbid conditions (high blood pressure, high cholesterol, etc) will be eligible

You may not qualify if:

• Patients with moderate or severe kidney disease and history of pancreatitis or patients on insulin will be excluded, as Exenatide use is contraindicated or risky in these conditions.
• Patients with unstable cardiac, neurological or psychiatric disease and women who are pregnant or trying to get pregnant will be excluded. Patients who have severe COPD, severe neuropathy or chronic pain, which could impair sleep, will be excluded. Shift workers will be also excluded.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Silvana Pannain, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 15, 2011
• Study Start: February 1, 2011
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

US (1)