NCT00901472

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

May 11, 2009

Last Update Submit

September 4, 2013

Conditions

Type 2 DiabetesObstructive Sleep Apnea

Keywords

Type 2 diabetes,obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • Improvement in glucose tolerance

    Day 1 to day 10.

Study Arms (1)

Stable type 2 Diabetes (ST2D)

Adults with Type 2 diabetes who receive medical care at the University of Chicago

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: NONE RETAINED

Blood was taken for HbA1C

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Eve Van Cauter, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 13, 2009

Study Start

February 1, 2007

Primary Completion

November 1, 2008

Study Completion

December 1, 2009

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)