CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,596 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03919734
NCT03919734N/ACompleted

Morbidity and Mortality in Patients With Adrenal Incidentalomas With and Without Autonomous Cortisol Secretion

Region Skane·observational·Posted Apr 18, 2019·Updated Mar 26, 2021

In Brief

An observational study for Adrenal Incidentaloma and Cortisol Overproduction. Completed, enrolled 4,596 participants across 1 site.

Detailed Summary

Benign enlargements of the adrenal glands (adrenal adenomas) are frequent in adults. In the general population these adenomas are rare in subjects below 40 years of age but at the age of 60 and 80 years the prevalence is 6 and 8-10 % respectively. Since these adenomas do not causes obvious symptoms they are almost exclusively found incidentally in patients examined radiologically for other reasons than suspected adrenal disease. These enlargements are thus termed adrenal incidentalomas (AI). AI may secrete cortisol and more than 25 percent of patients with an AI have increased cortisol levels called autonomous cortisol secretion (ACS). Such increased secretion of cortisol may cause metabolic complications such as hypertension, high cholesterol, diabetes and cardiovascular disease. Studies have shown that ACS may cause increased mortality. These studies are however small and have not adequately taking other conditions into account which most likely influences the result. The investigators hypothesis is that ACS is linked to increased mortality as the previous studies have shown. The aim is to perform a larger study on patients with adrenal incidentalomas, both with and without ACS, and compare the mortality rates with a control group matched for age and sex. This study may more precisely describe the cardiovascular risk for ACS and define the risk at different levels of ACS.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 18, 2019
Enrollment StartSep 15, 2015
Primary CompletionJan 3, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.2 years ago