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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02830308
Other study ID # 160125
Secondary ID 16-DK-0125
Status Recruiting
Phase
First received
Last updated
Start date July 9, 2016
Est. completion date December 31, 2029

Study information

Verified date March 11, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Marissa F Lightbourne, M.D.
Phone (301) 827-0033
Email marissa.lightbourne@nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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: 1. Collection of data for endocrine related conditions (case reports, case series) 2. Collection of data for future research 3. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1250
Est. completion date December 31, 2029
Est. primary completion date December 20, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility - INCLUSION CRITERIA: - 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. EXCLUSION CRITERIA: - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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