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Obesity, Sleep Apnea, and Insulin Resistance

Primary Purpose

Insulin Sensitivity, Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pioglitazone
placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Sensitivity focused on measuring obstructive sleep apnea, insulin sensitivity, cardiovascular risk, positive airway pressure therapy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy Individuals
  • Age 30-70 years old
  • BMI- 25-40 kg/m2
  • Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography

Exclusion Criteria:

  • Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer.
  • Must not have previously received treatment for OSA, including CPAP.
  • Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity.
  • Pregnancy/lactation is also an exclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    pioglitazone

    placebo

    Arm Description

    pioglitazone 45 mg, oral, daily

    Placebo, one pill daily

    Outcomes

    Primary Outcome Measures

    Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo
    To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 7, 2014
    Last Updated
    March 14, 2017
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02192684
    Brief Title
    Obesity, Sleep Apnea, and Insulin Resistance
    Official Title
    Interfacing Adiposity, Sleep Apnea, and Insulin Resistance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Sensitivity, Obstructive Sleep Apnea
    Keywords
    obstructive sleep apnea, insulin sensitivity, cardiovascular risk, positive airway pressure therapy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pioglitazone
    Arm Type
    Active Comparator
    Arm Description
    pioglitazone 45 mg, oral, daily
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, one pill daily
    Intervention Type
    Drug
    Intervention Name(s)
    Pioglitazone
    Other Intervention Name(s)
    actos
    Intervention Description
    45 mg daily Insulin sensitizing
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Compare with pioglitazone
    Primary Outcome Measure Information:
    Title
    Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo
    Description
    To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy Individuals Age 30-70 years old BMI- 25-40 kg/m2 Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography Exclusion Criteria: Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer. Must not have previously received treatment for OSA, including CPAP. Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity. Pregnancy/lactation is also an exclusion.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerald M Reaven, M.D.
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27544837
    Citation
    Liu A, Kim SH, Ariel D, Abbasi F, Lamendola C, Cardell J, Xu S, Patel S, Tomasso V, Mojaddidi H, Grove K, Tsao PS, Kushida CA, Reaven GM. Does enhanced insulin sensitivity improve sleep measures in patients with obstructive sleep apnea: a randomized, placebo-controlled pilot study. Sleep Med. 2016 Jun;22:57-60. doi: 10.1016/j.sleep.2016.06.005. Epub 2016 Jun 21.
    Results Reference
    derived

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    Obesity, Sleep Apnea, and Insulin Resistance

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