NCT00004326

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2002

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Cushing's Syndrome

Keywords

Cushing's syndromeendocrine disordersrare disease

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cushing SyndromeEndocrine System DiseasesRare Diseases

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Monica N. Starkman

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

August 1, 1994

Last Updated

June 24, 2005

Record last verified: 2002-04

Locations

US(1)