Back to resultsHippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome
Primary Purpose
Cushing's Syndrome
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cushing's Syndrome focused on measuring Cushing's syndrome, endocrine disorders, rare disease
Eligibility Criteria
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
Sites / Locations
- University of Michigan Health Systems
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004326
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00004326
Brief Title
Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome
Study Type
Observational
2. Study Status
Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
August 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Syndrome
Keywords
Cushing's syndrome, endocrine disorders, rare disease
7. Study Design
Enrollment
12 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica N. Starkman
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome
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