The Wellness Transformation Network Pilot Study
2022年4月21日 更新者：SciMar Ltd.
Establishment of a Standard Operating Procedure for Screening of the Pathologies Associated With Prediabetes and Diabetes -The Wellness Transformation Network Pilot Study.
The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes.
研究概览
详细说明
The proposed study will enable screening of pathologies associated with cardiometabolic diseases (i.e., hypertension, prediabetes, insulin resistance, diabetes, and obesity). The Meal-Induced Insulinemia and Glycemia (MIG) score will correlate with those dysfunctions that are components of the Absence of Meal-Induced Insulinemia (AMIS) syndrome. Overall the study aims:
- To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics.
- To compare a participant's MIG score and hepatalin levels following consumption of a standardized test meal containing macronutrients, and the measurement of several indices of organ health associated with diabetes (i.e., body composition, handgrip strength, spirometry, blood pressure, and heart rate variability).
The study will involve 2 study visits: Visit 1 - Screening and Visit 2 - Intervention (Test meal administration and postprandial blood collection).
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R2K 3Z5
- SNI Clinical Research
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults (males and females)18 years of age or older.
- Able to understand and communicate in English.
- Willing to answer a questionnaire on lifestyle and health status.
- Willing to undergo measurements of height, weight, waist circumference, hip circumference, blood pressure, heart rate and heart rate variability, body mass index, handgrip strength (handgrip dynamometry) testing, and pulmonary function (spirometry) testing.
- Willing to fast for 12 hours prior to two in-person study visits.
- Willing to consume a standardized test meal containing food ingredients.
- Willing to provide a urine sample.
- Willing to take a pregnancy test (female participants of childbearing potential).
- Willing to provide the research team with a listing of all current medications and Natural Health Products(NHPs).
- Willing to complete an online eDiary, including a 3-day food record.
- Willing to give blood samples (finger prick and blood sampling at defined intervals using an intravenous catheter)
Exclusion Criteria:
- Individuals diagnosed with diabetes.
- Women with confirmed pregnancy or who are breastfeeding.
- Individuals with allergy or sensitivity to any component of the standardized test meal (i.e., dextrose, lecithin, soy protein).
- Individuals with a fasting blood glucose of 7.0 mmol/L or higher.
- Individuals with abnormal glucose in their urine.
- Individuals who are related to or working for the clinic site, research staff, and study sponsor.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Acute Postprandial Blood Sampling
Two-hour postprandial blood sampling following administration of a standardized test meal
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During this study visit, a standardized test meal will be administered.
Blood samples will be collected at baseline and then every 30 minutes for 2 hours after test meal.
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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 |
|---|---|---|
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Establishment of proposed Wellness Transformation Network clinical trial procedures.
大体时间：2 Weeks
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Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No)
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2 Weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time course and curve analysis of serum glucose response after the test meal administration.
大体时间：Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Time course and curve analysis of serum insulin response after the test meal administration.
大体时间：Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Time course and curve analysis of serum triglycerides response after the test meal administration.
大体时间：Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Time course and curve analysis of plasma hepatalin response after the test meal administration.
大体时间：Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration.
大体时间：Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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MIG is calculated using the formula: MIG = (post meal insulin mIU/L X post meal glucose mmol/L) minus (fasted insulin mIU/L X fasted glucose mmol/L).
Higher score equates to a worse (unhealthy) outcome.
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Vanu Ramprasath, PhD、Source Nutraceutical, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年1月17日
初级完成 (实际的)
2022年4月5日
研究完成 (实际的)
2022年4月5日
研究注册日期
首次提交
2022年2月10日
首先提交符合 QC 标准的
2022年4月5日
首次发布 (实际的)
2022年4月6日
研究记录更新
最后更新发布 (实际的)
2022年4月22日
上次提交的符合 QC 标准的更新
2022年4月21日
最后验证
2022年4月1日
更多信息
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.