Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency

  • Observational
  • Recruiting
  • NCT03000231
Eligibility Details Visit Clinicaltrials.gov

Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency: a Case Control Study

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.

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy 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

At a Glance

National Government IDNCT03000231

IRB#IRB14-1484

Lead SponsorUniversity of Chicago

Lead PhysicianEve Van Cauter

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting