内分泌関連の状態と生理学の研究
内分泌関連の状態と生理学の評価と管理
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
調査の概要
詳細な説明
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:
- To provide a repository of data and samples obtained during the course of clinical care to allow for future research.
- To add value to the IEFP training program by maintaining a diverse group of endocrine conditions seen at the NIH.
- To provide a vehicle by which pilot studies of endocrine physiology can be initiated.
- To identify prismatic cases that deviate from known presentations or responses to treatment.
- To evaluate the safety and results from adrenal venous sampling using a modified catheter with side hole placement.
Endpoints:
- Data from standard of care evaluation and management.
- Adverse events during and after adrenal vein sampling; cortisol and aldosterone results from the sampling.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Raven N McGlotten, R.N.
- 電話番号：(301) 827-0190
- メール：mcglottenr@mail.nih.gov
研究連絡先のバックアップ
- 名前：Lynnette K Nieman, M.D.
- 電話番号：(301) 496-8935
- メール：niemanl@mail.nih.gov
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- 募集
- National Institutes of Health Clinical Center
-
コンタクト：
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- 電話番号：TTY8664111010 800-411-1222
- メール：prpl@cc.nih.gov
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
- 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
EXCLUSION CRITERIA:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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 |
one or two side-holes will be created by the interventional radiologist to facilitate adrenal vein sampling |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnosis/Treatment
時間枠：variable
|
determination of diagnosis and/or treatment of an endocrine disorder |
variable
|
協力者と研究者
捜査官
- 主任研究者：Lynnette K Nieman, M.D.、National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 190066
- 19-DK-0066
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。