Study of Endocrine-Related Conditions and Physiology

Официальное название

The Evaluation and Management of Endocrine-Related Conditions and Physiology

Обзор

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 ...

Подробное описание

Study Description:

This study allows the NIH Intramural Endocrinology Training Program (IETP) to follow or provide evaluation, treatment and or interventions to certain eligible subjects.

Objectives:

1. To provide a repository of data and samples obtained during the course of clinical care to allow for future research. 2. To add value to the IEFP training program by maintaining a diverse group of endocrine conditions seen at the NIH. 3. To provide a vehicle by which pilot studies of endocrine physiology can be initiated. 4. To identify prismatic cases that deviate from known presentations or responses to treatment. 5. To evaluate the safety and results from adrenal venous sampling using a modified catheter with side hole placement.

Endpoints:

1. Data from standard of care evaluation and management. 2. Adverse events during and after adrenal vein sampling; cortisol and aldosterone results from the sampling.

Вмешательства

• Устройство Creation of side holes in catheters for adrenal vein sampling
  one or two side-holes will be created by the interventional radiologist to facilitate adrenal vein sampling

Первичные конечные точки

• Diagnosis/Treatment [Срок оценки: variable]

Критерии участия

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all the following criteria:

• Adult men and women age 18 years or older.
• Known or suspected endocrine disorders requiring clinical screening, management and/or treatment and follow-up.
• Stated willingness to comply with all study procedures and availability for the duration of the study

Критерии исключения

• Unstable participants and participants 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.
• Inability of a subject to adhere to a proposed schedule of visits.
• Inability to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• National Institutes of Health Clinical Center — Bethesda

Идентификаторы

NCT: NCT03867448 · 190066 · 19-DK-0066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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