Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency: a Case Control Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adrenal Insufficiency
- Sponsor
- University of Chicago
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- day to day variability of sleep timing over 1 week of recording
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to compare cardio-metabolic risk, glucose tolerance, and night time blood pressure between healthy control subjects and patients with adrenal insufficiency. No intervention will be administered and the study is observational only.
Detailed Description
We propose to use a case control design to test the main hypothesis that as compared to healthy control subjects matched for sex, age, adiposity and race/ethnicity, patients with adrenal insufficiency, whether primary or secondary, have disturbances of the circadian system that are associated with high day to day variability of sleep time as well as elevated markers of cardio-metabolic risk, including abnormal oral glucose tolerance and reduced nocturnal blood pressure dipping. A secondary hypothesis of the study is that adrenal insufficiency patients on a replacement regimen (as part of their standard of care ongoing treatment) that results in daytime cortisol profiles approximating the normal diurnal variation will have better cardio-metabolic function than adrenal insufficiency patients who have grossly abnormal cortisol profiles.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary or secondary adrenal insufficiency, Healthy matched controls, acute or unstable health conditions age 18 or older
Exclusion Criteria
- •Diabetes, Tertiary adrenal insufficiency
Outcomes
Primary Outcomes
day to day variability of sleep timing over 1 week of recording
Time Frame: day 1 to day 7
On each day, the midpoint (time in hours and minutes) of the sleep period will be calculated and the variability over 1 week will be quantified by the standard deviation
Secondary Outcomes
- nocturnal blood pressure dipping(day 8 to 9)
- oral glucose tolerance(day 11 to 12)