Impact of Exenatide on Sleep in Type 2 Diabetes

NCT ID: NCT01136798

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-01
• Study Completion Date: 2016-09-01

Brief 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.

Conditions

Type 2 Diabetes; Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Usual T2 DM med regimen

Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Usual T2 DM med regimen plus Exenatide

Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Interventions

Exenatide

Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Intervention Type: DRUG

Placebo

Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eve Van Cauter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

09-291-B

Identifier Type: -

Identifier Source: org_study_id