NCT03867448

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Mar 2019Jan 2036

First Submitted

Initial submission to the registry

March 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
16.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2036

Last Updated

April 24, 2026

Status Verified

March 31, 2026

Enrollment Period

16.8 years

First QC Date

March 7, 2019

Last Update Submit

April 23, 2026

Conditions

Keywords

Adrenal GlandPituitaryNatural History

Outcome Measures

Primary Outcomes (1)

  • Diagnosis/Treatment

    determination of diagnosis and/or treatment of an endocrine disorder

    variable

Study Arms (2)

Adults with Endocrine Disorder

Adults referred to NIH with possible endocrine conditions

Adults with hyperaldosteronism

Adults referred to NIH or studied at NIH and determined to have hyperaldosteronism

Device: Creation of side holes in catheters for adrenal vein sampling

Interventions

one or two side-holes will be created by the interventional radiologist to facilitate adrenal vein sampling

Adults with hyperaldosteronism

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Endocrine System DiseasesPituitary Diseases

Interventions

Catheters

Condition Hierarchy (Ancestors)

Hypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Lynnette K Nieman, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raven N McGlotten, R.N.

CONTACT

Lynnette K Nieman, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 8, 2019

Study Start

March 27, 2019

Primary Completion (Estimated)

January 1, 2036

Study Completion (Estimated)

January 1, 2036

Last Updated

April 24, 2026

Record last verified: 2026-03-31

Locations