Study of Endocrine-Related Conditions and Physiology

Endocrine Disease Clinical Trial

Official title:

The Evaluation and Management of Endocrine-Related Conditions and Physiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03867448
• Other study ID #: 190066
• Secondary ID: 19-DK-0066
• Status: Recruiting
• Start date: March 27, 2019
• Est. completion date: January 1, 2036

Study information

• Verified date: May 7, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Raven N McGlotten, R.N.
• Phone: (301) 827-0190
• Email: mcglottenr[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2036
• Est. primary completion date: January 1, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Endocrine Disease
• Endocrine System Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis/Treatment	determination of diagnosis and/or treatment of an endocrine disorder	variable

External Links

•   NIH Clinical Center Detailed Web Page