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NCT00004326 Clinical Trial

Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome

Cushing's Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004326
Other study ID # 199/11872
Secondary ID UMMC-1043
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date August 1994

Study information
Verified date April 2002
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES: I. Evaluate whether chronic hypercortisolemia is specifically toxic to hippocampal cells and causes structural reduction of hippocampal volume in patients with Cushing's syndrome.

II. Determine whether reduced hippocampal volume is associated with specific memory dysfunction.

III. Examine the relationships of adrenal androgen to hippocampal volume and memory dysfunction.

IV. Examine the reversibility of hippocampal structural changes and cognitive dysfunction after cortisol levels are normalized.

Description:

PROTOCOL OUTLINE: Patients undergo a psychiatric evaluation for mood and cognition during confirmation of diagnosis. Neuropsychologic exams include pencil and paper test and a cognitive assessment.

Endocrine studies include dexamethasone and corticotropin-releasing hormone stimulation tests. The hippocampal complex volume is assessed with coronal magnetic resonance imaging.

There is a follow-up 1 year after the initiation of treatment.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 80 Years
Eligibility PROTOCOL ENTRY CRITERIA:

- Adults and teenagers with untreated, spontaneous active Cushing's syndrome

- Diagnosis verified at the University of Michigan Medical Center, including the following: Excessive cortisol secretion measured by urinary-free cortisol, cortisol secretion rate, and plasma cortisol level

- Lack of normal circadian cortisol secretion and failure to suppress following 2 mg of dexamethasone

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Michigan Health Systems Ann Arbor Michigan

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Michigan

Country where clinical trial is conducted

United States, 

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