Endocrine DiseasesNCT02830308
Evaluation of Adults With Endocrine and Metabolic-Related Conditions
An observational study of Endocrine Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: There are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine Diseases
- How many people
- 1,250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2016to 31 Dec 2029
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Clinical
Who may be able to join
- Participants with known or suspected endocrine disorder age 18 years and older are eligible for this protocol. Protocol investigators will make the actual selection of subjects most appropriate for clinical evaluation.
- Relatives ages 18 years and older may be enrolled if clinically indicated for the diagnosis of a proband.
Who cannot join
- Anyone under the age of 18 years old
- Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject. Subjects who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.
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
NIDDK DiabetesAndEndocrineClinic, Not Listed, diabetesandendocrineclinic@nih.gov
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: Evaluation of Adults With Endocrine-Related Conditions
Background:
There are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases.
Read more
Objectives:
To learn more about conditions that affect the hormone-secreting glands (endocrine glands) in adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions.
Eligibility:
Adults age 18 years and older with a known or suspected endocrine disorder.
Relatives ages 18 years and older.
Doctors will review all requests and available medical records to determine final eligibility for the protocol.
Design:
Participants will have a medical history and physical exam.
Most participants will have 1 visit, and may have follow up visits if necessary. They may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:
- Blood, urine, and saliva tests
- Imaging tests. These may include X-ray, ultrasound, or scans.
- Sleep study
- Medical photographs
- Visits with other specialists at NIH
Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may be stored in the freezer for future studies.
Participants may be asked to participate in genetic testing. They will give a blood or saliva sample for this.
Read the detailed description
This is an observational protocol designed to collect data from adult subjects with known or suspected endocrine or metabolic disorders.
OBJECTIVE: The overall purpose of endocrine evaluations under this protocol is to increase knowledge of endocrine or metabolic diseases. Adults with known or suspected endocrine or metabolic-related condition(s) may be evaluated under this protocol for:
- Collection of data for endocrine related conditions (case reports, case series)
- Collection of data for future research
- Collection of samples, including leftover samples from clinically indicated tests, for future research (including genomics)
METHODS: Patients will undergo a history and physical exam, anthropometrics, vital signs and endocrine laboratory studies.
- Conditions
- Endocrine Diseases
- Keywords
- Hormones, Endocrine, Hypercortisolism, Bone, Hypothalamic-Pituitary Dysfunction, Natural History
- Medical subject headings
- Endocrine System Diseases, Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with known or suspected endocrine or metabolic dissorde | Adults with known or suspected endocrine or metabolic dissorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruit a diverse population of adult subjects with a known or suspected endocrine or metabolic disorder in order to provide NIDDK investigators and trainees with hands-on experience related to the diagnosis, management, treatment, and follow-up...
The overall purpose of endocrine evaluations under this protocol is to support our clinical training and research missions.
Measured: 12/31/2036
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start9 Jul 2016
- Primary completion20 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endocrine DiseasesStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marissa F Lightbourne, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830308
- Sponsor's protocol ID
- 160125
- Other IDs
- 16-DK-0125
- Status last verified
- 24 Sep 2026
- First submitted
- 9 Jul 2016
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified results from clinical trials will be posted on cctrials.gov
Publications
Abd-Elmoniem KZ, Edwan JH, Dietsche KB, Villalobos-Perez A, Shams N, Matta J, Baumgarten L, Qaddumi WN, Dixon SA, Chowdhury A, Stagliano M, Mabundo L, Wentzel A, Hadigan C, Gharib AM, Chung ST. Endothelial Dysfunction in Youth-Onset Type 2 Diabetes: A Clinical Translational Study. Circ Res. 2024 Aug 30;135(6):639-650. doi: 10.1161/CIRCRESAHA.124.324272. Epub 2024 Jul 29.
PubMed 39069898
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adults With Endocrine-Related Conditions
- ClinicalTrials.gov ID
- NCT02830308
- Acronym / sponsor ID
- 160125
- Conditions
- Endocrine Diseases
- Keywords
- Hormones, Endocrine, Hypercortisolism, Bone, Hypothalamic-Pituitary Dysfunction, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 9 Jul 2016 (actual)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- 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:
There are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases.
Objectives:
To learn more about conditions that affect the hormone-secreting glands (endocrine glands) in adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions.
Eligibility:
Adults age 18 years and older with a known or suspected endocrine disorder.
Relatives ages 18 years and older.
Doctors will review all requests and available medical records to determine final eligibility for the protocol.
Design:
Participants will have a medical history and physical exam.
Most participants will have 1 visit, and may have follow up visits if necessary. They may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:
- Blood, urine, and saliva tests
- Imaging tests. These may include X-ray, ultrasound, or scans.
- Sleep study
- Medical photographs
- Visits with other specialists at NIH
Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may be stored in the freezer for future studies.
Participants may be asked to participate in genetic testing. They will give a blood or saliva sample for this.
Detailed description
This is an observational protocol designed to collect data from adult subjects with known or suspected endocrine or metabolic disorders.
OBJECTIVE: The overall purpose of endocrine evaluations under this protocol is to increase knowledge of endocrine or metabolic diseases. Adults with known or suspected endocrine or metabolic-related condition(s) may be evaluated under this protocol for:
- Collection of data for endocrine related conditions (case reports, case series)
- Collection of data for future research
- Collection of samples, including leftover samples from clinically indicated tests, for future research (including genomics)
METHODS: Patients will undergo a history and physical exam, anthropometrics, vital signs and endocrine laboratory studies.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with known or suspected endocrine or metabolic dissorde | – | –Adults with known or suspected endocrine or metabolic dissorders |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Clinical
Key inclusion criteria (2 listed)
- Participants with known or suspected endocrine disorder age 18 years and older are eligible for this protocol. Protocol investigators will make the actual selection of subjects most appropriate for clinical evaluation.
- Relatives ages 18 years and older may be enrolled if clinically indicated for the diagnosis of a proband.
Key exclusion criteria (2 listed)
- Anyone under the age of 18 years old
- Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject. Subjects who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruit a diverse population of adult subjects with a known or suspected endocrine or metabolic disorder in order to provide NIDDK investigators and trainees with hands-on experience related to the diagnosis, management, treatment, and follow-up...
Time frame: 12/31/2036
The overall purpose of endocrine evaluations under this protocol is to support our clinical training and research missions.
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 28 Sep 2026.
- Derived from this study: PubMed 39069898Abd-Elmoniem KZ, Edwan JH, Dietsche KB, Villalobos-Perez A, Shams N, Matta J, Baumgarten L, Qaddumi WN, Dixon SA, Chowdhury A, Stagliano M, Mabundo L, Wentzel A, Hadigan C, Gharib AM, Chung ST. Endothelial Dysfunction in Youth-Onset Type 2 Diabetes: A Clinical Translational Study. Circ Res. 2024 Aug 30;135(6):639-650. doi: 10.1161/CIRCRESAHA.124.324272. Epub 2024 Jul 29.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified results from clinical trials will be posted on cctrials.gov
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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.
Marissa F Lightbourne, 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 Diseases, 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 2 inclusion and 2 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 28 Sep 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 Marissa F Lightbourne, M.D. ((301) 827-0033, diabetesandendocrineclinic@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruit a diverse population of adult subjects with a known or suspected endocrine or metabolic disorder in order to provide NIDDK investigators and trainees with hands-on experience related to the diagnosis, management, treatment, and follow-up... (time frame: 12/31/2036). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830308, which also lists 1 linked publication.
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 28 Sep 2026.