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
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
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
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
Learn more about this trial
Obesity, Sleep Apnea, and Insulin Resistance
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