Obesity, Sleep Apnea, and Insulin Resistance

Obstructive Sleep Apnea Clinical Trial

Official title:

Interfacing Adiposity, Sleep Apnea, and Insulin Resistance

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02192684
• Other study ID #: 5U01HL108647-04
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 7, 2014
• Last updated: July 16, 2014
• Start date: September 2010
• Est. completion date: June 2015

Study information

• Verified date: July 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Apnea
• Insulin Resistance
• Insulin Sensitivity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Pioglitazone
45 mg daily Insulin sensitizing
• placebo
Compare with pioglitazone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in insulin sensitivity outcome measure in response to CPAP	Evaluate the effect of CPAP on insulin resistance and cardiometabolic risk factors in patients with OSA.	12 weeks	No
Primary	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.	8 weeks	No
Secondary	Change in insulin sensitivity outcome measure in response to pioglitazone or placebo	Change in insulin sensitivity in patients with OSA randomized to pioglitazone or placebo.	8 weeks	No