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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Temple University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT00194259
First received: September 13, 2005
Last updated: March 5, 2014
Last verified: January 2008
  Purpose

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.


Condition
Obstructive Sleep Apnea
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Apnea in Look AHEAD (Action for Health in Diabetes)

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Effects of OSA on weight [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Saliva Samples


Estimated Enrollment: 320
Study Start Date: August 2001
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Type II diabetes previously enrolled into the "Look-AHEAD" Study. Comid diagnosis of sleep apnea

Criteria

Inclusion Criteria:

  • Enrollment in LookAhead
  • Type II Diabetes and Sleep Apnea

Exclusion Criteria:

  • Determined by parent study, LookAhead
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194259

Locations
United States, New York
St. Luke's Roosevelt Hospital
New York, New York, United States, 10025
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Temple University
University of Pennsylvania
Investigators
Principal Investigator: Gary D Foster, Ph.D. Temple University
Principal Investigator: Richard Millman, M.D. Brown University
Principal Investigator: Mark Sanders, AB, MD, FCCP, D'ABSM University of Pittsburgh
Principal Investigator: Gary Zammit, Ph.D. St. Luke's-Roosevelt Hospital Center
Principal Investigator: Samuel T Kuna, M.D. University of Pennsylvania
  More Information

No publications provided by Temple University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00194259     History of Changes
Obsolete Identifiers: NCT00350740
Other Study ID Numbers: HL70301
Study First Received: September 13, 2005
Last Updated: March 5, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Apnea
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 25, 2014