NCT03000231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

8.2 years

First QC Date

December 19, 2016

Last Update Submit

February 23, 2024

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • nocturnal blood pressure dipping

    day 8 to 9

  • oral glucose tolerance

    day 11 to 12

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Diabetes, Tertiary adrenal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Eve Van Cauter, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 22, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)