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The Diagnostic Performance of Screening Tests for the Diagnosis of Cushing's Syndrome


N/A
18 Years
75 Years
Open (Enrolling)
Both
Cushing's Syndrome

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Trial Information

The Diagnostic Performance of Screening Tests for the Diagnosis of Cushing's Syndrome


Cushing's syndrome is a rare disorder characterized by a variety of clinical signs and
symptoms that reflect chronic exposure to hypercortisolism such as obesity, hypertension,
glucose intolerance, infections, psychiatric disturbance, impaired cognition and
hypercoagulability. Thus, it is important to screen for this treatable disorder so as to
prevent its associated morbidity and mortality. Because many of the signs of Cushing's
syndrome are common in the general population, information about the cost-effectiveness and
diagnostic efficiency of various screening tests would be useful.

This study will evaluate the diagnostic performance of various screening tests for Cushing's
syndrome in overweight patients recruited from a weight loss center who have additional
signs of the disorder. Patients with abnormal tests will be seen as outpatients at the NIH
for further evaluation for up to two years to confirm or refute the possibility that they
have Cushing's syndrome. Patients with the disorder will be treated.

Inclusion Criteria


- INCLUSION CRITERIA:

Patients presenting for weight loss treatment at the GWUWMP

Patients must have at least two of the signs and symptoms in Table 1 of the protocol, in
addition to weight gain. If abdominal pain, backache and/or headache are present, only
one of these symptoms can be used in any given patient, so that another feature must be
present.

Willing and able to be seen for up to 24 months

Age 18-75

EXCLUSION CRITERIA:

Weight more than 350 pounds, the maximum weight for radiologist examination tables
necessary for the evaluation of Cushing's Syndrome

Renal failure, creatinine greater than 2.6, because of possible effects on dexamethasone
metabolism

Pregnancy, because it alters interpretation of adrenal function tests

Current use of oral, inhaled or intranasal glucocorticoids or use within 30 days of study

Other significant medical disorders that may complicate participation or interpretation of
the results. For example, a patient with a collagen vascular disorder who has taken
intermittent high dose glucocorticoids, and might need to do this again, might not be
offered participation.

Use of black licorice or chewing tobacco within two weeks of the study or anticipated use
during the study

Use of phenytoin, barbiturate, loperamide or opiates within two weeks of the study or
anticipated chronic use during the study.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Lynnette K Nieman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Authority:

United States: Federal Government

Study ID:

020309

NCT ID:

NCT00361777

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Cushing's Syndrome
  • Cortisol
  • Dexamethasone
  • Obesity
  • Pseudo-Cushing State
  • Hypercortisolism
  • Cushing's Syndrome
  • Cushing Syndrome
  • Cushing Syndrome

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892
GW University Medical Center GW Hospital Center Washington, District of Columbia  20037