Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency
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|ClinicalTrials.gov Identifier: NCT03000231|
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : February 9, 2017
|Condition or disease|
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|
|Estimated Enrollment :||24 participants|
|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|
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.
- 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
- 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000231
|Contact: Eve Van Cauter, Ph.D.||firstname.lastname@example.org|
|Contact: Susan Sam, M.D.||email@example.com|
|United States, Illinois|
|The University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Eve Van Cauter, PhD 773-702-0169 firstname.lastname@example.org|
|Contact: Susan Sam, MD 773-702-5641 email@example.com|
|Principal Investigator: Eve Van Cauter, PhD|
|Principal Investigator:||Eve Van Cauter, Ph.D.||University of Chicago|