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| Name | Class |
|---|---|
| Source Nutraceutical, Inc. | INDUSTRY |
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The proposed clinical trial is a controlled study of n=24 healthy adult individuals tested in both the Meal-Induced Insulin Sensitization (MIS) state and, following atropine blockade, Absence of Meal-Induced Insulin Sensitization (AMIS) state to differentiate the postprandial glycemia, insulinemia, triglyceride and Hepatic Insulin Sensitizing Substance (HISS) levels in the two states.
The purpose of this study is the identification and development of biometric markers which incorporate the actions and interplay between insulin and HISS. Overall, the study aims to:
The study will involve 4 study visits: Visit 1 - Prescreening; Visit 2 - Screening; Visit 3 - Liquid test meal administration and postprandial blood collection; Visit 4 - Atropine administration + Liquid test meal administration and postprandial blood collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized liquid test meal | Experimental |
| |
| Atropine + Standardized liquid Test meal | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized liquid test meal | Other | During this study visit, a standardized liquid test meal will be administered. Blood samples will be collected at baseline and then every 30 minutes for 4 hours after test meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Time course change in serum glucose | Time course and curve analysis of serum glucose response after the test meal administration with and without atropine pre-treatment. | Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration |
| Time course change in serum insulin | Time course and curve analysis of serum insulin response after the test meal administration with and without atropine pre-treatment | Time Frame: Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration |
| Time course change in serum triglycerides | Time course and curve analysis of serum triglycerides response after the test meal administration with and without atropine pre-treatment | Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration |
| Time course change in plasma HISS levels | Time course and curve analysis of plasma HISS response after the test meal administration with and without atropine pre-treatment | Time Frame: Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time course change in serum free fatty acids | Time course and curve analysis of serum free fatty acid response after the test meal administration with and without atropine pre-treatment | Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after 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 |
|---|---|---|---|---|---|---|
| Kalo Medical Clinic | Winnipeg | Manitoba | R2K 3Z5 | Canada |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Atropine + Standardized liquid test meal | Drug | During this study visit, 1.0 mg atropine will be administered I.V and then a standardized liquid test meal will be administered. Blood samples will be collected at baseline, following atropine administration, and then every 30 minutes for 4 hours after test meal. |
|
| Time course change in plasma lactate | Time course and curve analysis of plasma lactate response after the test meal administration with and without atropine pre-treatment | Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration |
| Time frame fasted HOMA-IR (Molar Units) | Time frame HOMA-IR, calculated using the formula: fasting insulin (mIU/L) X fasting glucose (mmol/L) | Control: Baseline fasted Test: 15 mins post atropine |
| Time course change in Meal Induced Glycemia (MIG) scores (Molar Units) | Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration with and without atropine pre-treatment. 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 | Control: Every 30 minutes up to 4 hours after test meal administration; Test: Every 30 minutes up to 4 hours after test meal administration |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |