Current partner codePEPTIDESDE
NCT01416649·Not applicable·OBSERVATIONAL

Impact of Exenatide on Sleep Duration

Status

Completed

Phase

Not applicable

Enrollment

8

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Exenatide

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.

Timeline

From registration to results.

  1. First posted

    Aug 15, 2011

  2. Study start

    Feb 1, 2011

  3. Primary completion

    Apr 21, 2021

  4. Study completion

    Apr 21, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Apr 26, 2023

Outcomes

What the study measures.

Primary outcomes

Sleep duration and sleep efficiency

Time frame · at the end of 3 months of treatment with the medication

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 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 Exclusion Criteria: 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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

The University of Chicago

Chicago, Illinois, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.