Evaluation of Adults With Endocrine and Metabolic-Related Conditions

NCT02830308 | Recruiting

• 2 other identifiers: 16012516-DK-0125
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endocrine Diseases

Keywords

Hormones; Endocrine; Hypercortisolism; Bone; Hypothalamic-Pituitary Dysfunction; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  12/31/2036

Study Arms (1)

Adults with known or suspected endocrine or metabolic dissorde

Adults with known or suspected endocrine or metabolic dissorders

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Clinical

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39069898 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Endocrine System Diseases; Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases

Study Officials

• Marissa F Lightbourne, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa F Lightbourne, M.D.

CONTACT

(301) 827-0033; marissa.lightbourne@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2016
• First Posted: July 12, 2016
• Study Start: July 9, 2016
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04-23

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Not otherwise specified in protocol.
• Access Criteria: Only investigators will have access to the data. Publications will not include subject names, nor will they contain personal identifying information. De-identified results from clinical trials will be posted on cctrials.gov

Locations

US (1)