Obesity, Sleep Apnea, and Insulin Resistance

NCT02192684 | Completed Results DMC

• 1 other identifier: 5U01HL108647-04
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insulin Sensitivity; Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; insulin sensitivity; cardiovascular risk; positive airway pressure therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

pioglitazone

ACTIVE COMPARATOR

pioglitazone 45 mg, oral, daily

Drug: Pioglitazone

placebo

PLACEBO COMPARATOR

Placebo, one pill daily

Drug: placebo

Interventions

Pioglitazone DRUG

45 mg daily Insulin sensitizing

Also known as: actos

pioglitazone

placebo DRUG

Compare with pioglitazone

placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Individuals
• Age 30-70 years old
• BMI- 25-40 kg/m2
• Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Related Publications (1)

• 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.

  PMID: 27544837 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Sleep Apnea, Obstructive

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Unrecognized adverse effect of pioglitazone could have obviated a beneficial effect of enhanced insulin sensitivity on OSA related sleep measures.

Results Point of Contact

• Title: Dr. Gerald Reaven
• Organization: Stanford Universtiy

greaven@stanford.edu

650-724-3416

Study Officials

• Gerald M Reaven, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 17, 2014
• Study Start: September 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-03