Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome

NCT ID: NCT00004326

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

1994-08-31

Brief Summary

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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

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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.

Conditions

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Cushing's Syndrome

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Monica N. Starkman

Role: STUDY_CHAIR

University of Michigan

Locations

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University of Michigan Health Systems

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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UMMC-1043

Identifier Type: -

Identifier Source: secondary_id

199/11872

Identifier Type: -

Identifier Source: org_study_id