Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency

The University of Chicago

Status: Completed

Conditions: Adrenal Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT03000231

14-1484

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

Healthy Controls

Description:

Matched by age, race, gender and BMI to adrenal insufficiency subjects

Adrenal Insufficiency Patients

Description:

Eligible patients will have either primary adrenal insufficiency or secondary adrenal insufficiency and will be age 18 and older.