Diagnostic Performance of Screening Tests for Cushing s Syndrome
|First Received Date ICMJE||August 8, 2006|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||September 18, 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00361777 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Diagnostic Performance of Screening Tests for Cushing s Syndrome|
|Official Title ICMJE||The Diagnostic Performance of Screening Tests for the Diagnosis of Cushing's Syndrome|
This study will test the accuracy of screening tests for Cushing s syndrome in overweight people with signs of the disorder. Cushing s syndrome is a rare disorder caused by excess production of the hormone cortisol. Patients may have various problems, such as weight gain, high blood pressure, diabetes, infections, mood problems, trouble concentrating, and increased blood clotting. These symptoms are seen in many other disorders as well, complicating the diagnosis. The reliability of tests currently used to diagnose Cushing s syndrome is not known. To test their accuracy, subjects in this study who test positive for Cushing s syndrome will be evaluated at NIH for 2 years to either confirm or refute the laboratory results.
Patients between 18 and 75 years of age who are being treated at the George Washington University Weight Management Program (GWUWMP) may participate in this study. Candidates will be screened with a medical history, physical examination, measurement of body fat, blood tests, and oral glucose tolerance test. They will also complete a symptoms checklist and quality of life questionnaire.
Participants will be tested for Cushing s syndrome with a saliva collection, 24-hour urine collection, and dexamethasone suppression test (DST). For the DST they will take 1 mg of dexamethasone at night and report to GWUWMP the next morning for a blood draw. All specimens blood, saliva, and urine will be tested for cortisol levels.
People whose test results are abnormal will be seen at the NIH outpatient clinic for a medical history, physical examination, and blood tests; bedtime saliva collection; two 24-hour urine collections; and a 2-day 2-mg DST, followed by administration of corticotropin-releasing hormone (CRH). CRH is a naturally occurring hormone that causes cortisol levels to rise. Pre-treatment with dexamethasone prevents CRH from causing an increase in cortisol in healthy people, but not in patients with Cushing s syndrome. For the 2-day DST, the subject takes 0.5 mg dexamethasone every 6 hours for eight doses. Two hours after the last dose, CRH is injected through a catheter (thin plastic tube) inserted into an arm vein. Blood is drawn just before giving CRH to measure dexamethasone and cortisol levels and after giving CRH to measure cortisol levels.
People whose test results are normal will not be seen further at NIH. Those with high cortisol levels will have repeat urine and saliva tests every 2 to 8 weeks for up to 24 months, and a 1-mg DST every 3 months during routine clinic visits at GWUWMP. People whose increased cortisol is found to be due to another condition besides Cushing s syndrome will be referred for evaluation and possible treatment. Those diagnosed with Cushing s syndrome will have standard tests to identify the tumor causing the disorder, followed by standard medical and surgical treatment.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Cushing's Syndrome|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
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.
|Ages||18 Years to 75 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00361777|
|Other Study ID Numbers ICMJE||020309, 02-CH-0309|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Study Sponsor ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 8, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP