NCT00031239

Brief Summary

To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics with obstructive sleep apnea.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

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

Study Start

First participant enrolled

September 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2002

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 29, 2016

Status Verified

May 1, 2009

Enrollment Period

4.8 years

First QC Date

February 27, 2002

Last Update Submit

July 28, 2016

Conditions

Sleep Apnea SyndromesDiabetes Mellitus, Non-insulin DependentObesityDiabetes Mellitus

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
An estimated 176 obese, diabetic subjects with obstructive sleep apnea, 50% women and 40% minorities.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Foster GD. Principles and practices in the management of obesity. Am J Respir Crit Care Med. 2003 Aug 1;168(3):274-80. doi: 10.1164/rccm.200205-456PP. No abstract available.

    PMID: 12888610BACKGROUND

MeSH Terms

Conditions

Sleep Apnea SyndromesDiabetes Mellitus, Type 2ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gary Foster

    University of Pennsylvania

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

February 27, 2002

First Posted

February 28, 2002

Study Start

September 1, 2001

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

July 29, 2016

Record last verified: 2009-05