Study of Endocrine-Related Conditions and Physiology

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.

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

Study Overview

• Status: Recruiting
• Conditions: Endocrine Disease

Detailed Description

This protocol is designed to allow inpatient and outpatient evaluation of adults with a variety of

endocrine disorders for purposes of research and physician education in our accredited internal medicine endocrinology training programs. Participants will receive clinical care per standard of practice for their condition. Data collected from standard clinical practice will be retained for future research. The research-directed evaluations may include collection and retention for future use of blood, feces, saliva, or urine samples or evaluation of tissue that was routinely collected for clinical care. In some patients with endocrine disorders, laboratory or radiological studies will be performed to confirm a diagnosis or to aid in the management of the patient, using standard approaches in current clinical practice. In some cases, the patient will receive medical, radiation or surgical treatment for their disorder.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Raven N McGlotten, R.N.; Phone Number: (301) 827-0190; Email: mcglottenr@mail.nih.gov
• Study Contact Backup: Name: Lynnette K Nieman, M.D.; Phone Number: (301) 496-8935; Email: niemanl@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY8664111010 800-411-1222; Email: prpl@cc.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

• INCLUSION CRITERIA:
• Age 18 years or greater.
• The possible disorder of the patient subjects must complement the case-mix in the IETP, as determined by the Principal Investigator. A log will be used to assure that the training needs of the teaching protocols are being met.

EXCLUSION CRITIERIA:

1. Unstable patients and patients 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. Decisions will be made on a case by case basis by the investigators. For example, there is a weight limit for the interventional radiology table used for venous sampling.
2. Inability of a subject to adhere to a proposed schedule of visits.
3. Individuals must be able to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adults with Endocrine Disorder; Adults referred to NIH with possible endocrine conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis/Treatment	determination of diagnosis and/or treatment of an endocrine disorder	variable

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Lynnette K Nieman, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: February 8, 2024

More Information

Terms related to this study

• Keywords: Natural History; Pituitary; Adrenal Gland
• Additional Relevant MeSH Terms: Endocrine System Diseases
• Other Study ID Numbers: 190066; 19-DK-0066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No