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Evaluation of Patients with Endocrine-Related Conditions



Evaluation of Patients with Endocrine-Related Conditions

For Condition: Hyperinsulinemia,Type II Diabetes Mellitus,Glucose Intolerance,Impaired Glucose Tolerance,Non Insulin Dependent Diabetes Mellitus,Endocrine Disease,Obesity
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: This study will evaluate patients with a variety of endocrine disorders in order to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) to train physicians in endocrinology. Patients of all ages with endocrine-related conditions may be eligible for evaluation under this protocol. Those enrolled may be required to provide blood, saliva, urine or stool samples, and to undergo ultrasound examination of the thyroid gland, ovaries or testes, adrenal glands or other parts of the body. Laboratory or X-ray studies may be done for diagnostic or treatment purposes. In some cases, patients will receive medical or surgical treatment for their disorder. Patients and family members of patients with a hereditary disorder may be asked to provide a blood sample for genetic analysis.
Details: This protocol is designed to allow inpatient and outpatient evaluation of patients with a variety of endocrine disorders for purposes of research and physician education in our accredited endocrinology training programs. The research-directed evaluations may include blood, saliva, urine or stool samples, and/or ultrasound examinations. In some cases, laboratory or radiological studies will be performed to confirm the diagnosis or to aid in the management of the patient, as would be done in current clinical practice. In some cases, the patient will receive medical or surgical treatment for their disorder. The purpose of these evaluations or treatments will be to support our clinical training or research missions.
Eligibility:
Study Type:
  Interventional, Training
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients of all ages with endocrine-related conditions will be eligible for this protocol. EXCLUSION CRITERIA: Unstable patients and patients with severe organ failure that may affect/limit the endocrine work-up and exhaust Clinical Center and/or NICHD resources will be excluded. Hematologic abnormalities: platelets less than 100,000 cells/mm(3), hemoglobin less than 10 mg/dl and/or WBC less than 3,000 cells/mm(3). Cardiovascular disorders: Clinical evidence of congestive heart failure, unstable angina. Hepatic/Renal Dysfunction: Severe hepatic insufficiency (SGOT, SGPT, alkaline phosphatase, total bilirubin) greater than 200% of the upper limit of normal); serum creatinine greater than 2.0 mg/dl. Respiratory distress: Ventilator-dependent patients. Advanced and/or multiple non-endocrine disorders. SALIVARY CORTISOL PILOT STUDY: INCLUSION CRITERIA: Only adults with consistent bedtimes by midnight will be studied. EXCLUSION CRITERIA: Suspected hypercortisolism or the use of glucocorticoids in any form within the last six months will be exclusion criteria. SALIVARY ALDOSTERNEL PILOT STUDY: INCLUSION CRITERIA: Patients with confirmed primary hyperaldosteronism will be studied. EXCLUSION CRITERIA: Suspected use of spironolactone in any form within the 4 weeks will be exclusion criteria.
Total Enrollment: 800

Location and Contact Information:

National Institute of Child Health and Human Development (NICHD) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:
  000127;  00-CH-0127
Study Start Date: May 9, 2000
Record last reviewed: March 30, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005664

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