Obesity, Sleep Apnea, and Insulin Resistance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sleep Apnea in Type 1 Diabetes

NCT01935765

Type 1 Diabetes, Sleep Apnea Syndrome

COMPLETED NA

Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

NCT00896298

Hypoleptinemia Generalized Lipodystrophy Partial Lipodystrophy +1 more

COMPLETED PHASE2/PHASE3

Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes

NCT00212290

Insulin Resistance Type 2 Diabetes Mellitus

COMPLETED PHASE4

The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans

NCT02403284

Insulin Resistance

COMPLETED PHASE4

The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers

NCT02229487

Prediabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Sensitivity Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pioglitazone

pioglitazone 45 mg, oral, daily

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

45 mg daily Insulin sensitizing

placebo

Placebo, one pill daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Compare with pioglitazone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pioglitazone

45 mg daily Insulin sensitizing

Intervention Type DRUG

placebo

Compare with pioglitazone

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

actos

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes