Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency

Completed

• Conditions: Adrenal Insufficiency

• Registration Number: NCT03000231
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-22
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Primary or secondary adrenal insufficiency, Healthy matched controls, acute or unstable health conditions age 18 or older

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Exclusion Criteria

• Diabetes, Tertiary adrenal insufficiency

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States