Clinical Trial: Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: University of Chicago

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • nocturnal blood pressure dipping [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University of Chicago

Dates:
Date Received: December 19, 2016
Date Started: October 2015
Date Completion: December 2017
Last Updated: February 7, 2017
Last Verified: February 2017