Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Insufficiency

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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

• Study Contact: Name: Eve Van Cauter, Ph.D.; Phone Number: 773-7020169; Email: evcauter@medicine.bsd.uchicago.edu
• Study Contact Backup: Name: Susan Sam, M.D.; Phone Number: 773-7025641; Email: ssam@medicine.bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary or secondary Adrenal Insufficiency age 18 and older and healthy matched control subjects

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Controls; Matched by age, race, gender and BMI to adrenal insufficiency subjects
Adrenal Insufficiency Patients; Eligible patients will have either primary adrenal insufficiency or secondary adrenal insufficiency and will be age 18 and older.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
day to day variability of sleep timing over 1 week of recording	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	day 1 to day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nocturnal blood pressure dipping	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	day 8 to 9
oral glucose tolerance	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.	day 11 to 12

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Eve Van Cauter, Ph.D., University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimated): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenal Insufficiency
• Other Study ID Numbers: 14-1484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO