Endocrine Studies in Health and Disease

This study has been terminated.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00006073

First Posted: July 14, 2003

Last Update Posted: October 6, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

Purpose

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:

CRH stimulation test corticotropin-releasing hormone is given to test pituitary and adrenal gland function
ACTH stimulation test adrenocorticotrophic hormone is given to test adrenal gland function
LHRH stimulation test luteinizing hormone-releasing hormone is given to test pituitary gland function
TRH stimulation test thyroid-releasing hormone is given to test pituitary and thyroid gland function
GHRH stimulation test growth hormone releasing hormone is given to measure growth hormone levels.

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.

Condition
Endocrine Diseases


Study Type:	Observational
Study Design:	Time Perspective: Other
Official Title:	Endocrine Studies in Health and Disease

Further study details as provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):


Enrollment:	3090
Study Start Date:	July 19, 2000
Estimated Study Completion Date:	August 31, 2016

Detailed Description:

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 99 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA

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 their 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006073

Locations


United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

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

Investigators


Principal Investigator:	Margaret F Keil, C.R.N.P.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information


Responsible Party:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00006073 History of Changes
Other Study ID Numbers:	000180 00-CH-0180
First Submitted:	July 25, 2000
First Posted:	July 14, 2003
Last Update Posted:	October 6, 2017
Last Verified:	August 31, 2016

Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):


Evaluation Endocrinology Hormones	Metabolism Teaching Endocrine Disorder

Additional relevant MeSH terms:


Endocrine System Diseases

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