Endocrine Studies in Health and Disease
|First Received Date ICMJE||July 25, 2000|
|Last Updated Date||March 14, 2014|
|Start Date ICMJE||July 2000|
|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 NCT00006073 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||Endocrine Studies in Health and Disease|
|Official Title ICMJE||Endocrine Studies in Health and Disease|
This study will evaluate healthy normal volunteers and patients with a variety of endocrine disorders to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) train physicians in endocrinology.
Patients with endocrine-related conditions and healthy volunteers of all ages may be eligible for this study.
All participants will have a physical examination medical and history. They may be required to provide blood, saliva or urine samples and undergo ultrasound (using sound waves) or magnetic resonance (using a magnetic field) imaging to visualize internal body structures.
Some healthy adult volunteers will have hormone-stimulating tests to assess endocrine function. These tests measure blood hormone levels before and after injection of a synthetic form of a hormone. A device called a heparin lock, through which the hormone is injected and the blood samples are collected, is placed in a vein in the arm or hand. Blood samples are drawn before the hormone is injected and at various intervals after the injection to measure levels of the hormone. These tests, which last from 1 to 3 hours, may include the following:
An oral glucose tolerance test, which is similar to the stimulation tests, may also be done to measure blood glucose (sugar) and insulin levels after drinking a sugary liquid.
Healthy volunteers and patients with a hereditary endocrine disorder and their family members may also be asked to provide a blood sample for genetic studies of inherited endocrine disorders. Patients with endocrine-related disorders may be offered medical or surgical treatment for their disorder.
AcAccess http://turners.nichd.nih.gov/ for additional study publications.
This protocol is designed to allow endocrine-related evaluations of healthy subjects and patients with a variety of endocrine disorders. Healthy subjects may be studied to obtain normative data for endocrine tests involving blood, urine, saliva, ultrasound and magnetic resonance examinations. If not eligible for a specific NICHD research protocol, patients with endocrine-related conditions may be evaluated under the auspices of this protocol to advance the clinical skills of physicians participating in NICHD clinical research and training programs, and to provide stimuli for new clinical research initiatives. Standard, medically-indicated laboratory or radiological studies may be performed to confirm a diagnosis or to aid in the management of the patient. In some cases, the patient will receive medical or surgical treatment for their disorder, according to current clinical practice. The overall purpose of endocrine evaluations under this protocol is to support our clinical training and research missions.
|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||Endocrine Diseases|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||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||Recruiting|
|Estimated Enrollment ICMJE||3500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Healthy subjects and patients with endocrine-related conditions of all ages are eligible for this protocol. The actual selection of patients most appropriate for clinical training needs will be made by protocol investigators.
Subjects with disabilities are not formally excluded from the study unless the disability would specifically prevent participation. If a subject with cognitive impairment wishes to participate, there must be available a family member or other qualified individual holding a durable power of attorney who is able to guide the impaired subject's participation and be an advocate for their interests. This participation is limited to the non-research, clinical training arm of the study.
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00006073|
|Other Study ID Numbers ICMJE||000180, 00-CH-0180|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|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||November 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP