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临床试验/NCT03867448
NCT03867448招募中不适用

The Evaluation and Management of Endocrine-Related Conditions and Physiology

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Diagnosis/Treatment

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Adults with Endocrine Disorder

Adults referred to NIH with possible endocrine conditions

Adults with hyperaldosteronism

Adults referred to NIH or studied at NIH and determined to have hyperaldosteronism

干预措施: Creation of side holes in catheters for adrenal vein sampling (Device)

结局指标

主要结局

Diagnosis/Treatment

时间窗: variable

determination of diagnosis and/or treatment of an endocrine disorder

次要结局

未报告次要终点

研究者

研究点 (1)

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