Study of Endocrine-Related Conditions and Physiology

NCT ID: NCT03867448

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2036-01-01

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

Study Description:

This study allows the NIH Intramural Endocrinology Training Program (IETP) to follow or provide evaluation, treatment and or interventions to certain eligible subjects.

Objectives:

1. To provide a repository of data and samples obtained during the course of clinical care to allow for future research.

2. To add value to the IEFP training program by maintaining a diverse group of endocrine conditions seen at the NIH.

3. To provide a vehicle by which pilot studies of endocrine physiology can be initiated.

4. To identify prismatic cases that deviate from known presentations or responses to treatment.

5. To evaluate the safety and results from adrenal venous sampling using a modified catheter with side hole placement.

Endpoints:

1. Data from standard of care evaluation and management.

2. Adverse events during and after adrenal vein sampling; cortisol and aldosterone results from the sampling.

Conditions

Endocrine Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults with Endocrine Disorder

Adults referred to NIH with possible endocrine conditions

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all the following criteria:

• Adult men and women age 18 years or older.
• Known or suspected endocrine disorders requiring clinical screening, management and/or treatment and follow-up.
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

• Unstable participants and participants 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.
• Inability of a subject to adhere to a proposed schedule of visits.
• Inability to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynnette K Nieman, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Raven N McGlotten, R.N.

Role: CONTACT

mcglottenr@mail.nih.gov

(301) 827-0190

Lynnette K Nieman, M.D.

Role: CONTACT

niemanl@mail.nih.gov

(301) 496-8935

Facility Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Role: primary

prpl@cc.nih.gov

800-411-1222 ext. TTY8664111010

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2019-DK-0066.html

NIH Clinical Center Detailed Web Page

Other Identifiers

19-DK-0066

Identifier Type: -

Identifier Source: secondary_id

190066

Identifier Type: -

Identifier Source: org_study_id