Home Sleep and Circadian Phase: Mediators of Diabetes Risk

Northwestern University1 site in 1 country120 target enrollmentDecember 6, 2011

ConditionsSleep Deprivation Diabetes Circadian Dysregulation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Deprivation
Sponsor: Northwestern University
Enrollment: 120
Locations: 1
Primary Endpoint: Oral Disposition Index
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if deficient sleep and/or disruption with the body's internal clock ("circadian rhythms") are associated with diabetes risk. This study is being done to look at the possible relationships between sleep and risk of diabetes by examining sleep in the home and diabetes risk in the laboratory.

Registry

clinicaltrials.gov

Start Date

December 6, 2011

End Date

September 30, 2019

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Northwestern University

Responsible Party

Principal Investigator

Kristen Knutson

Associate Professor

Northwestern University

Eligibility Criteria

Inclusion Criteria

•Ages 21-50 years
•BMI \<40 kg/m
•No major illness.
•No history of psychiatric, endocrine, cardiac or sleep disorders,
•Premenopausal, non-pregnant women.
•Those with dyslipidemia and hypertension will be included if these conditions are controlled by a stable treatment, such as lipid-lowering or antihypertensive medications (except beta blockers).
•Exclusion criteria include:
•Persons with diabetes.
•Persons with diagnosed sleep disorders or apnea-hypopnea index\>
•History of cardiovascular event or disease (excluding controlled hypertension).

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Oral Disposition Index

Time Frame: baseline

The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response.