Sleep Disturbances as a Non-traditional Risk Factor in CK... | NCT00817674

Studies
Sleep Disturbances as a Non-traditional Risk Factor in CKD-Actigraphy

NCT00817674

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Sep 5, 2013Estimated

Enrollment

353Actual

Phase

Not provided

Conditions

Chronic Kidney Disease
Sleep Loss

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R01DK071696	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jan 5, 2009

First Submission Date that Met QC Criteria

Jan 5, 2009

First Posted Date

Jan 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2013

Last Update Posted Date

Sep 5, 2013Estimated

Name	Class
University of Illinois at Chicago	OTHER
Case Western Reserve University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To test if usual at home night time sleep duration as measured with activity monitors and questionnaires will predict changes in kidney function as measured by kidney filtration rate and of cardiovascular function as measured by C-reactive protein in the blood. The study will explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk factor for the progression of CKD and for the development of cardiovascular disease in CKD.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

353Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		CKD subjects
2		Healthy Controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period		5 years

Secondary Outcomes

Measure	Description	Time Frame
insulin resistance		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to Moderate CKD
Healthy controls age and gender matched to CKD subjects
Regular bedtimes of at least 6h/night, sedentary lifestyle

Exclusion Criteria:

Diabetes
Current or previous dialysis for more than 1 month
Uncontrolled hypertension
Heart failure
Liver disease
HIV
Hemoglobin < 10.5 g/dl
Treatment with EProcrit, Epogen, or Aranesp
Bone or organ transplant,
Use of immunosuppressive drugs within past 6 months
Current oral contraceptive use
Current pregnancy
Chemotherapy for malignancy within past 2 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

CKD subjects; healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eve Van Cauter, PhD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Chicago		Chicago	Illinois	60637	United States

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided