Clinical trial NCT03867448: Study of Endocrine-Related Conditions and Physiology
Official title: The Evaluation and Management of Endocrine-Related Conditions and Physiology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endocrine Disease
Keywords: Adrenal Gland
Pituitary
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2019-03-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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.

Primary outcomes:
measure: Diagnosis/Treatment
timeFrame: variable
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Lynnette K Nieman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: