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Study of Endocrine-Related Conditions and Physiology

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ClinicalTrials.gov Identifier: NCT03867448
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Background:

Endocrine disorders involve changes to glands that produce hormones. Hormones are released by these glands into the blood so they can direct the function of other tissues in the body. Researchers want to study people who may have endocrine disorders. They want to learn more about the conditions that affect endocrine glands.

Objective:

To study adults with a variety of endocrine disorders for research and physician education.

Eligibility:

Adults ages 18 and older who have an endocrine or metabolic-related disorder

Healthy volunteers 18 and older

Design:

Participants will be screened with a review of their medical records.

Participants will have a physical exam and medical history.

The length of the study and the schedule will vary by participant. Tests may include:

Blood and urine tests

Stool and saliva samples

Imaging studies: Participants will lie on a table while a machine takes pictures of the body. They may be injected with a substance to make their organs more visible in the pictures.

Tests of endocrine tissue function

Consultation with other specialists

Sleep study

Medical photographs

Participants may be treated for their endocrine disorder. This could include:

Surgery. If tissue is removed during surgery, it may be studied.

Radiation

Medicine

Participants may have genetic testing. This will be done with a small amount of blood, cells from a cheek swab, or saliva.

Sponsoring Institution: National Institute of Digestive, Diabetes and Kidney Disease


Condition or disease
Endocrine Disease

Detailed Description:

This protocol is designed to allow inpatient and outpatient evaluation of adults with a variety of

endocrine disorders for purposes of research and physician education in our accredited internal medicine endocrinology training programs. Participants will receive clinical care per standard of practice for their condition. Data collected from standard clinical practice will be retained for future research. The research-directed evaluations may include collection and retention for future use of blood, feces, saliva, or urine samples or evaluation of tissue that was routinely collected for clinical care. In some patients with endocrine disorders, laboratory or radiological studies will be performed to confirm a diagnosis or to aid in the management of the patient, using standard approaches in current clinical practice. In some cases, the patient will receive medical, radiation or surgical treatment for their disorder.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Evaluation and Management of Endocrine-Related Conditions and Physiology
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : January 1, 2030
Estimated Study Completion Date : January 1, 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Adults with Endocrine Disorder
Adults referred to NIH with posssible endocrine conditions.


Outcome Measures
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Primary Outcome Measures :
  1. Diagnosis/Treatment [ Time Frame: variable ]
    determination of diagnosis and/or treatment of an endocrine disorder


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
any adult with a potential endocrine disorder; the types of disorders may vary to ensure that there is an adequate case mix of diagnoses for the training program.
Criteria
  • INCLUSION CRITERIA:
  • Age 18 years or greater.
  • The possible disorder of the patient subjects must complement the case-mix in the IETP, as determined by the Principal Investigator. A log will be used to assure that the training needs of the teaching protocols are being met.

EXCLUSION CRITIERIA:

  1. Unstable patients and patients with severe organ failure, or those with a condition or medical treatment that may affect/limit the endocrine work-up and exhaust Clinical Center, IETP resources will be excluded if appropriate. Decisions will be made on a case by case basis by the investigators. For example, there is a weight limit for the interventional radiology table used for venous

    sampling.

  2. Inability of a subject to adhere to a proposed schedule of visits.
  3. Individuals must be able to provide informed consent.
Contacts and Locations
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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): NCT03867448


Contacts
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Contact: Lynnette K Nieman, M.D. (301) 496-8935 niemanl@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Lynnette K Nieman, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Additional Information:

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT03867448    
Other Study ID Numbers: 190066
19-DK-0066
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: August 26, 2021
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Adrenal Gland
Pituitary
Natural History
Additional relevant MeSH terms:
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Endocrine System Diseases