- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192684
Obesity, Sleep Apnea, and Insulin Resistance
March 14, 2017 updated by: Gerald M Reaven, Stanford University
Interfacing Adiposity, Sleep Apnea, and Insulin Resistance
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: pioglitazone
pioglitazone 45 mg, oral, daily
|
45 mg daily Insulin sensitizing
Other Names:
|
Placebo Comparator: placebo
Placebo, one pill daily
|
Compare with pioglitazone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
July 7, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 17, 2014
Study Record Updates
Last Update Posted (Actual)
April 21, 2017
Last Update Submitted That Met QC Criteria
March 14, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Hyperinsulinism
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Hypersensitivity
- Apnea
- Insulin Resistance
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Pioglitazone
Other Study ID Numbers
- 5U01HL108647-04 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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