NCT00371293

Brief Summary

Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation and heart conditions, but it is unknown whether this risk is related to the effects of OSA or obesity. This study will evaluate whether OSA or obesity plays the primary role in inflammation related to heart disease. The study will also determine the independent effects of OSA and obesity on insulin resistance and blood vessel function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

April 5, 2017

Completed
Last Updated

April 5, 2017

Status Verified

February 1, 2017

Enrollment Period

6 years

First QC Date

September 1, 2006

Results QC Date

December 4, 2014

Last Update Submit

February 18, 2017

Conditions

Sleep Apnea SyndromesInflammation

Keywords

Sleep ApneaC-Reactive ProteinObesityInsulin ResistanceArterial stiffness

Outcome Measures

Primary Outcomes (1)

  • Inflammation

    Measured at Baseline and Week 24

Secondary Outcomes (4)

  • Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)

    Measured at Baseline and Week 24

  • Change in LDL Cholesterol Levels

    Measured at Baseline and Week 24

  • Change in Triglyceride Levels

    Measured at Baseline and Week 24

  • Change in HDL Cholesterol Levels

    Measured at Baseline and Week 24

Study Arms (3)

1

ACTIVE COMPARATOR

Participants will receive CPAP therapy.

Device: CPAP therapy

2

ACTIVE COMPARATOR

Participants will take part in a weight loss program.

Behavioral: Weight Loss Program

3

EXPERIMENTAL

Participants will receive CPAP therapy and take part in a weight loss program.

Behavioral: Weight Loss ProgramDevice: CPAP therapy

Interventions

Weight Loss ProgramBEHAVIORAL

Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.

23
CPAP therapyDEVICE

Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.

13

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe OSA (as defined by an apnea-hypopnea index \[AHI\] score greater than 15 events per hour)
  • Body mass index greater than 30 kg/m
  • Baseline CRP greater than 1.0 mg/dL

You may not qualify if:

  • Predominant central sleep apnea
  • Type 1 Diabetes
  • Type 2 Diabetes associated with either: (a) unstable anti-diabetic therapy (anti-diabetic medication changes within past 3 months); (b) Hemoglobin A1C levels \> 7%; (c) Inability to perform home blood glucose monitoring (fingerstick checks).
  • Requires use of supplemental oxygen
  • Acute coronary syndrome or stroke in the 3 months prior to study entry
  • A high-risk occupation or motor vehicle driving record, as defined by a score of 10 points or higher on an occupational and driving habits questionnaire
  • Blood pressure greater than 160/95 mm Hg (may be re-screened after blood pressure control is obtained)
  • Active infection, cancer, or chronic inflammatory disorder
  • Use of systemic steroids
  • Currently on an unstable dose of statin therapy (participants taking statins must be on a stable dose for at least 8 weeks prior to study entry)
  • Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)
  • Consumes more than 14 alcoholic drinks per week
  • History of surgery in the 3 months prior to study entry
  • Sustained ventricular or supraventricular tachycardia greater than 30 seconds during overnight sleep study
  • Known left ventricular ejection fraction less than 30% or decompensated congestive heart failure requiring hospitalization in the year prior to study entry
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19014, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19014, United States

Location

Related Publications (2)

  • Jain S, Gurubhagavatula I, Townsend R, Kuna ST, Teff K, Wadden TA, Chittams J, Hanlon AL, Maislin G, Saif H, Broderick P, Ahmad Z, Pack AI, Chirinos JA. Effect of CPAP, Weight Loss, or CPAP Plus Weight Loss on Central Hemodynamics and Arterial Stiffness. Hypertension. 2017 Dec;70(6):1283-1290. doi: 10.1161/HYPERTENSIONAHA.117.09392. Epub 2017 Oct 16.

    PMID: 29038203DERIVED

  • Chirinos JA, Gurubhagavatula I, Teff K, Rader DJ, Wadden TA, Townsend R, Foster GD, Maislin G, Saif H, Broderick P, Chittams J, Hanlon AL, Pack AI. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2265-75. doi: 10.1056/NEJMoa1306187.

    PMID: 24918371DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesInflammationObesityInsulin Resistance

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Julio Chirinos
Organization
UPenn
julio.chirinos@uphs.upenn.edu
2158235800

Study Officials

  • Julio A. Chirinos, MD

    University of Pennsylvania, Philadelphia Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2012

Study Completion

December 1, 2013

Last Updated

April 5, 2017

Results First Posted

April 5, 2017

Record last verified: 2017-02

Locations

US(2)