青少年和成人糖尿病与肥胖临床谱系的评估
青年与成人糖尿病和肥胖症临床谱系评估
Background:
Diabetes and obesity are chronic diseases. They can affect blood flow and how the body processes nutrients, and complications over time can lead to early death. Diabetes can affect children as well as adults, but the disease seems to be more severe and to progress faster when it appears in younger people. Researchers want to understand more about how diabetes and obesity develop and change over time.
Objective:
To collect data and samples regularly from people with obesity and diabetes.
Eligibility:
People aged 8 to 65 years. They must be overweight or obese; or have high blood sugar; or have problems with how their body uses food for energy.
Design:
Participants will have additional procedures during routine care visits at the NIH clinic.
Data collected for the study will include the following:
Information from the participant s medical chart will be kept for research.
Questionnaires will ask about participant s eating habits, feelings, sleep, and substance use. They will take 30 to 60 minutes. Care providers will address any issues revealed in these surveys.
Blood, saliva, urine, and stool samples will be collected. Samples may be used for genetic tests.
Data and samples will be kept for future research.
Participants may remain in the study up to 30 years.
研究概览
详细说明
Study Description:
This is a single-site observational study conducted at the NIH Clinical Center. Youth and adults who have suspected or established hyperglycemia, overweight or obesity, or metabolic disease, or who require clinical screening for such conditions are provided standard clinical care. Data and samples obtained during regular clinical care will be retained for future research. Recommendations for other treatment options outside of the NIH will be discussed with study participants and may be discussed with their primary or referring physicians.
The schedule a participant follows will be based on their unique clinical needs.
Objectives:
To collect data and samples during clinical evaluation, treatment, and follow-up of participants for use in future studies.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Noemi Malandrino, M.D.
- 电话号码：(301) 402-4006
- 邮箱：noemi.malandrino@nih.gov
学习地点
-
-
Maryland
-
Bethesda、Maryland、美国、20892
- National Institutes of Health Clinical Center
-
接触：
- Noemi Malandrino, M.D.
- 电话号码：301-402-4006
- 邮箱：noemi.malandrino@nih.gov
-
接触：
- Lilian Mabundo
- 电话号码：(240) 383-9379
- 邮箱：lilian.mabundo@nih.gov
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
This is a single-site observational study conducted at the NIH Clinical Center. Youth and adults who have suspected or established hyperglycemia, overweight or obesity, or metabolic disease, or who require clinical screening for such conditions are provided standard clinical care. Data and samples obtained during regular clinical care will be retained for future research. Recommendations for other treatment options outside of the NIH will be discussed with study participants and may be discussed with their primary or referring physicians. The schedule a participant follows will be based on their unique clinical needs.
描述
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
-
Age 8 years to 65 years
-
Meet at least one of the following:
a. Overweight/Obesity:
i. For participants under 18 years of age: BMI >= 85th percentile for age and sex
ii. For participants >= 18 years of age: BMI >= 25 kg/m^2 (>=23 kg/m^2 for self-reported Asian race/ethnicity)
b. Suspected or evidence of hyperglycemia:
i. Diagnosis of prediabetes or diabetes in medical history or by participant/guardian/Legally Authorized Representative (LAR) report, OR
ii. Fasting blood glucose >= 100 mg/dL in medical record, OR
iii. Postprandial blood sugar >= 140 mg/dL in medical record, OR
iv. Hemoglobin A1c >= 5.7% in medical record
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- History of significant medical illnesses that the investigators feel may interfere with potential evaluations, i.e. individuals 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.
- History of any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the participant.
- Inability or unwillingness of participant, parent/guardian, or LAR to provide informed consent.
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
|---|
|
Adults with suspected or established hyperglycemia, overweight or obesity, or metabolic disease
Data and samples will be obtained during complete comprehensive clinical screening procedures and provision of standard of care treatments. Data and samples to be retained may include either residual samples/ data not otherwise needed for clinical care or additional samples/ data collected during the course of clinical care. These data will provide information to prevent the development and/or progression of cardiovascular disease and other diabetes-related complications, to increase the understanding of these disease processes in patients with different age of onset of metabolic disease, and how available treatments affect the prognosis in these patients. |
|
Youth with suspected or established hyperglycemia, overweight or obesity, or metabolic disease
Data and samples will be obtained during complete comprehensive clinical screening procedures and provision of standard of care treatments. Data and samples to be retained may include either residual samples/ data not otherwise needed for clinical care or additional samples/ data collected during the course of clinical care. These data will provide information to prevent the development and/or progression of cardiovascular disease and other diabetes-related complications, to increase the understanding of these disease processes in patients with different age of onset of metabolic disease, and how available treatments affect the prognosis in these patients. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To collect data and samples during clinical evaluation, treatment, and follow-up of participants for use in future studies.
大体时间：Up to 30 years
|
Samples including whole blood, saliva/buccal swabs, urine, and/or stool will be collected and stored for use in future studies to test our hypothesis that individuals with youth and adult early-onset diabetes and obesity will have high rates of metabolic complications and rapid disease progression compared to adults who develop diabetes later in their life. These samples will be collected during the participants' clinical care visits |
Up to 30 years
|
合作者和调查者
调查人员
- 首席研究员：Noemi Malandrino, M.D.、National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 10002229
- 002229-DK
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
For associate protocols, identifiable data will be de-identified prior to repository submission. Participant level clinical data related to primary outcomes, will be preserved through deposition of the data in a controlled access public repository.
IPD 共享时间框架
Scientific data will be shared as soon as possible. Scientific data included in published manuscript will be available at the time of publication. All other generated data will be shared no later than at the end of the award.
IPD 共享访问标准
The study protocol, data dictionary and a glossary of domain-specific terms to facilitate interpretation of scientific data related to primary outcomes will be submitted.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.