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Completed

NCT Number: NCT03000231

Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency

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.

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Key information

Conditions

Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2016
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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