Adrenal Insufficiency
Conditions
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.
Interventions
None listed
Sponsors
University of Chicago
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| day to day variability of sleep timing over 1 week of recording | 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
| Measure | Time frame | Description |
|---|---|---|
| nocturnal blood pressure dipping | day 8 to 9 | a 24-h recording of blood pressure will be conducted in the laboratory with concurrent sleep recording. Dipping will be calculated as the difference between the daytime mean and the nighttime mean |
| oral glucose tolerance | day 11 to 12 | A 3-h 75g oral glucose tolerance test will be performed in the laboratory after an overnight fast. Glucose tolerance will be quantified by the total area under the glucose curve over the 3-hour period of sampling. |
Countries
United States
Outcome results
None listed