Clinical trialNCT00194259UnknownObservational

Sleep Apnea in Look AHEAD (Action for Health in Diabetes)

SponsorTemple UniversityEnrollment320Obstructive Sleep ApneaType 2 Diabetes

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will assess the effects of weight loss on sleep-disordered breathing (SDB) in 120 obese, type 2 diabetics with obstructive sleep apnea (OSA) from four Look AHEAD sites. Changes in SDB will be compared between subjects randomized to weight loss (Lifestyle Intervention Group) versus non-weight loss (Diabetes Education and Support Group) conditions within the context of the Look AHEAD Study. Weight loss is frequently recommended for obese patients with OSA, but the empirical foundation for this recommendation is not well substantiated. Weight loss in obese apneics improves but does not eliminate SDB. Moreover, the degree of improvement is not correlated with the amount of weight loss. This study will assess SDB before treatment and at 1 and 2 years. We will also investigate clinical measures of fat distribution that may mediate the non-linear relationship between weight loss and improvements in SDB. Finally, we will examine the role of SDB in mediating changes in blood pressure associated with weight loss.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Gary D Foster, Ph.D.
Temple University
Principal Investigator
clinicaltrials.gov ↗
Gary Zammit, Ph.D.
St. Luke's-Roosevelt Hospital Center
Principal Investigator
clinicaltrials.gov ↗
Mark Sanders, AB, MD, FCCP, D'ABSM
University of Pittsburgh
Principal Investigator
clinicaltrials.gov ↗
Richard Millman, M.D.
Brown University
Principal Investigator
clinicaltrials.gov ↗
Samuel T Kuna, M.D.
University of Pennsylvania
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

St. Luke'S Roosevelt Hospital
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2001
Primary completion: 30 Jun 2014
Completion: 30 Jun 2014
Last update posted: 7 Mar 2014
Registered enrollment: 320
Registry id: NCT00194259

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.