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Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03000231
Recruitment Status : Unknown
Verified February 2017 by University of Chicago.
Recruitment status was:  Recruiting
First Posted : December 22, 2016
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency: a Case Control Study
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03000231

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Contact: Eve Van Cauter, Ph.D. 773-7020169
Contact: Susan Sam, M.D. 773-7025641

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United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Eve Van Cauter, PhD    773-702-0169   
Contact: Susan Sam, MD    773-702-5641   
Principal Investigator: Eve Van Cauter, PhD         
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Eve Van Cauter, Ph.D. University of Chicago

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Responsible Party: University of Chicago Identifier: NCT03000231    
Other Study ID Numbers: 14-1484
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents