Obesity, Sleep Apnea, and Insulin Resistance

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gerald M Reaven, Stanford University
ClinicalTrials.gov Identifier:
NCT02192684
First received: July 7, 2014
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Insulin Sensitivity
Obstructive Sleep Apnea
Drug: Pioglitazone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Interfacing Adiposity, Sleep Apnea, and Insulin Resistance

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in apnea-hypopnea index (AHI) outcome measure in response to pioglitazone or placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.


Secondary Outcome Measures:
  • Change in insulin sensitivity outcome measure in response to pioglitazone or placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in insulin sensitivity in patients with OSA randomized to pioglitazone or placebo.


Other Outcome Measures:
  • Change in insulin sensitivity outcome measure in response to CPAP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate the effect of CPAP on insulin resistance and cardiometabolic risk factors in patients with OSA.


Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pioglitazone
pioglitazone 45 mg, oral, daily
Drug: Pioglitazone
45 mg daily Insulin sensitizing
Placebo Comparator: placebo
Placebo, one pill daily
Drug: placebo
Compare with pioglitazone

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Gerald M Reaven, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT02192684     History of Changes
Other Study ID Numbers: 5U01HL108647-04
Study First Received: July 7, 2014
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
obstructive sleep apnea
insulin sensitivity
cardiovascular risk
positive airway pressure therapy

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Insulin Resistance
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014