Endocrine DiseaseNCT03867448
Study of Endocrine-Related Conditions and Physiology
An observational study of Endocrine Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Endocrine Disease
- What is being tested?
- Creation of side holes in catheters for adrenal vein sampling
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2019to 1 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Official title: The Evaluation and Management of Endocrine-Related Conditions and Physiology
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.
Read more
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
Read the 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:
- To provide a repository of data and samples obtained during the course of clinical care to allow for future research.
- To add value to the IEFP training program by maintaining a diverse group of endocrine conditions seen at the NIH.
- To provide a vehicle by which pilot studies of endocrine physiology can be initiated.
- To identify prismatic cases that deviate from known presentations or responses to treatment.
- To evaluate the safety and results from adrenal venous sampling using a modified catheter with side hole placement.
Endpoints:
- Data from standard of care evaluation and management.
- Adverse events during and after adrenal vein sampling; cortisol and aldosterone results from the sampling.
- Conditions
- Endocrine Disease
- Being tested
- Creation of side holes in catheters for adrenal vein sampling
- Keywords
- Adrenal Gland, Pituitary, Natural History
- Medical subject headings
- Endocrine System Diseases, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creation of side holes in catheters for adrenal vein samplingDevice
one or two side-holes will be created by the interventional radiologist to facilitate adrenal vein sampling
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Creation of side holes in catheters for adrenal vein sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis/Treatment
determination of diagnosis and/or treatment of an endocrine disorder
Measured: variable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start27 Mar 2019
- Primary completion1 Jan 2036 (estimated)
- Study completion1 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lynnette K Nieman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867448
- Sponsor's protocol ID
- 190066
- Other IDs
- 19-DK-0066
- Status last verified
- 3 Sep 2026
- First submitted
- 7 Mar 2019
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: WE currently have no plan to share this data, but in the future may consider sharing of this data for analysis with collaborators of with other expertise.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation and Management of Endocrine-Related Conditions and Physiology
- ClinicalTrials.gov ID
- NCT03867448
- Acronym / sponsor ID
- 190066
- Conditions
- Endocrine Disease
- Keywords
- Adrenal Gland, Pituitary, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 1 Jan 2036 (estimated)
- Study completion
- 1 Jan 2036 (estimated)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To provide a repository of data and samples obtained during the course of clinical care to allow for future research.
- To add value to the IEFP training program by maintaining a diverse group of endocrine conditions seen at the NIH.
- To provide a vehicle by which pilot studies of endocrine physiology can be initiated.
- To identify prismatic cases that deviate from known presentations or responses to treatment.
- To evaluate the safety and results from adrenal venous sampling using a modified catheter with side hole placement.
Endpoints:
- Data from standard of care evaluation and management.
- Adverse events during and after adrenal vein sampling; cortisol and aldosterone results from the sampling.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with Endocrine Disorder | – | –Adults referred to NIH with possible endocrine conditions |
| Adults with hyperaldosteronism | – | Device: Creation of side holes in catheters for adrenal vein samplingAdults referred to NIH or studied at NIH and determined to have hyperaldosteronism |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creation of side holes in catheters for adrenal vein samplingone or two side-holes will be created by the interventional radiologist to facilitate adrenal vein sampling | Device | Adults with hyperaldosteronism |
Primary outcome
Diagnosis/Treatment
Time frame: variable
determination of diagnosis and/or treatment of an endocrine disorder
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. WE currently have no plan to share this data, but in the future may consider sharing of this data for analysis with collaborators of with other expertise.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynnette K Nieman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raven N McGlotten, R.N. ((301) 827-0190, mcglottenr@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis/Treatment (time frame: variable). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.