Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Michigan

Investigators

  • Study Chair: Monica N. Starkman, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1994

Study Registration Dates

First Submitted

October 18, 1999

First Submitted That Met QC Criteria

October 18, 1999

First Posted (Estimate)

October 19, 1999

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/11872
  • UMMC-1043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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