Sleep Disordered Breathing and Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00901472
First received: May 11, 2009
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

The hypothesis of this study is: sleep disordered breathing (SDB), specifically, obstructive sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition.

In an exploration of this hypothesis, the investigators hope to provide evidence linking SDB to increased severity of disease in the type 2 diabetic patient. By doing so, the investigators ultimately seek to support investigating the use of SDB interventions as an additional method of care in the treatment of type 2 diabetes.


Condition
Type 2 Diabetes
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sleep Disordered Breathing and Blood Glucose Control in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Improvement in glucose tolerance [ Time Frame: Day 1 to day 10. ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Blood was taken for HbA1C


Enrollment: 105
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stable type 2 Diabetes (ST2D)
Adults with Type 2 diabetes who receive medical care at the University of Chicago

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians in the endocrinology or primary care clinic will self-identify themselves for participation in response to flyers posted at the check-in desk.

Criteria

Inclusion Criteria:

  • adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians

Exclusion Criteria:

  • patients with the diagnosis of type 1 diabetes (DM); newly diagnosed Type 2 DM patients
  • patients with the diagnosis of OSA using CPAP for either 4 or more hours per night or 5 nights per week
  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: NCT00901472

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00901472     History of Changes
Other Study ID Numbers: #14903B
Study First Received: May 11, 2009
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Type 2 diabetes,
obstructive sleep apnea

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

ClinicalTrials.gov processed this record on September 22, 2014