Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Endocrine-Related Conditions and Physiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867448
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief 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. 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

...


Condition or disease
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. The research-directed evaluations may include 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. The purpose of these evaluations or treatments is to support our clinical training or research missions. Future small pilot studies may be performed to investigate certain endocrine questions; these will be presented to the IRB as they arise.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Evaluation and Management of Endocrine-Related Conditions and Physiology
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : September 1, 2028
Estimated Study Completion Date : November 1, 2028

Resource links provided by the National Library of Medicine


Group/Cohort
1
inpatient and outpatient evaluation of adults with a variety of endocrine disorders



Primary Outcome Measures :
  1. Diagnosis/Treatment [ Time Frame: variable ]
    determination of diagnosis and/or treatment of an endocrine disorder



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria
  • INCLUSION CRITERIA:

    1. Age 18 years or greater.
    2. 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.
    3. Pregnant women/fetuses are not an intended cohort for the study the study is not intended to explore specific aspects of pregnancy or fetal development. However, pregnant women may be enrolled into the protocol for standard evaluation and/or care that has the prospect of providing direct benefit. They may also provide biospecimens for research studies. Pregnancy tests will be performed

      before any drugs are given or imaging is performed, on all women of reproductive age (18 -50 years) if they have had menses in the last year. In general, testing would be limited to minimal risk tests, such as blood withdrawal, study of urine, feces or saliva, use of provocative tests that must be performed to establish a diagnosis, and are considered safe for both mother and fetus, and/or imaging that is both essential and safe, such as ultrasound or non-contrast MRI. No radioactive material or radiation will be administered.

    4. NIH employees are eligible to participate. Employee enrollment is not anticipated in this protocol, but if an employee wants to be enrolled in the study with the prospect of direct benefit in accordance with the NIH HRPP SOP 14F they may be enrolled. However, the Principal Investigator will take the following steps to ensure that there are adequate protections in place to protect the confidentiality of

employee health information and minimize any pressure or discomfort of the employee with the consent process: 1. A member of the research team will provide the NIH Information Sheet on Employee Research Participation, and NIH policy 2300-630-3 to employees who are considering enrolling in research to help them understand NIH requirement and possible consequences. 2. If a member of the research team is the supervisor of the employee-subject, an independent person (e.g. bioethics staff) will monitor the consent process. 3. The Principal Investigator will require that study staff who may have contact with sensitive data about a co-worker or subordinate complete the Just-in-Time CITI course Biomedical Vulnerable Subjects-Workers/Employees.

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, NIDDK and/or NICHD 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. Because there is a potential for research studies under this protocol, individuals must be able to provide informed consent. The inability to provide informed consent will be an exclusion criterion. However, if patients have previously given consent, and become unable to provide informed consent, they will continue to be seen for ongoing clinical care only. If they require medically-indicated

procedures, we will follow NIH policy regarding obtaining consent from next of kin if they have not indicated a medical decision maker.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867448


Contacts
Layout table for location contacts
Contact: Lynnette K Nieman, M.D. (301) 496-8935 niemanl@mail.nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Lynnette K Nieman, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT03867448     History of Changes
Other Study ID Numbers: 190066
19-DK-0066
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 12, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Adrenal Gland
Pituitary
Additional relevant MeSH terms:
Layout table for MeSH terms
Endocrine System Diseases