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Obesity, Sleep Apnea, and Insulin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02192684
First Posted: July 17, 2014
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerald M Reaven, Stanford University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Interfacing Adiposity, Sleep Apnea, and Insulin Resistance

Resource links provided by NLM:


Further study details as provided by Gerald M Reaven, Stanford University:

Primary Outcome Measures:
  • Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo [ Time Frame: 8 weeks ]
    To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.


Enrollment: 45
Study Start Date: September 2010
Study Completion Date: March 2015
Primary Completion Date: July 2014 (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
Other Name: actos
Placebo Comparator: placebo
Placebo, one pill daily
Drug: placebo
Compare with pioglitazone

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192684


Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Gerald M Reaven, M.D. Stanford University
  More Information

Responsible Party: Gerald M Reaven, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT02192684     History of Changes
Other Study ID Numbers: 5U01HL108647-04 ( U.S. NIH Grant/Contract )
First Submitted: July 7, 2014
First Posted: July 17, 2014
Results First Submitted: November 18, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: March 2017

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

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