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| Name | Class |
|---|---|
| Source Nutraceutical, Inc. | INDUSTRY |
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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.
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:
The study will involve 2 study visits: Visit 1 - Screening and Visit 2 - Intervention (Test meal administration and postprandial blood collection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Postprandial Blood Sampling | Experimental | Two-hour postprandial blood sampling following administration of a standardized test meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized test meal | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Establishment of proposed Wellness Transformation Network clinical trial procedures. | Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No) | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time course and curve analysis of serum glucose response after the test meal administration. | Test: Baseline, every 30 minutes up to 2 hours after test meal administration | |
| Time course and curve analysis of serum insulin response after the test meal administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanu Ramprasath, PhD | Source Nutraceutical, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNI Clinical Research | Winnipeg | Manitoba | R2K 3Z5 | Canada |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D007333 | Insulin Resistance |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| Test: Baseline, every 30 minutes up to 2 hours after test meal administration |
| Time course and curve analysis of serum triglycerides response after the test meal administration. | Test: Baseline, every 30 minutes up to 2 hours after test meal administration |
| Time course and curve analysis of plasma hepatalin response after the test meal administration. | Test: Baseline, every 30 minutes up to 2 hours after test meal administration |
| Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration. | 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. | Test: Baseline, every 30 minutes up to 2 hours after test meal administration |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |