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Completed

NCT Number: NCT01136798

Impact of Exenatide on Sleep in Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Apnea Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disordered Breathing Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exenatide

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Non-REM Slow Wave Sleep

    Time frame: baseline and after 6 weeks of treatment

    Total minutes of non-REM sleep was measured

  2. Total Amount of Slow Wave Activity

    Time frame: baseline and after 6 weeks of treatment

    Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured

Secondary outcomes

  1. Sleep Efficiency During Polysomnographic Recording

    Time frame: baseline and after 6 weeks of treatment

    Sleep efficiency will be calculated as total sleep time over total recording time.

  2. Minutes of Wake After Sleep Onset During Sleep Recording

    Time frame: baseline and after 6 weeks of treatment

    total amount of time spent awake after sleep onset and before morning awakening will be calculated

  3. Severity of Obstructive Sleep Apnea

    Time frame: baseline and after 6 weeks of treatment

    The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea.

  4. Mean 24-h Blood Glucose Levels

    Time frame: baseline and after 6 weeks of treatment

    Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2010
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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