The Efficacy and Tolerability of Acarbose in Healthy Individuals

Study Overview
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Brief Summary
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A Prospective Trial for Acarbose in Healthy Individuals Assessing Safety and Efficacy in Reducing Glucose Spikes After Carbohydrate Consumption.

Official Title
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The Efficacy and Tolerability of Acarbose in Healthy Individuals: A Prospective Trial for Acarbose in Healthy Individuals Assessing Safety and Efficacy in Reducing Glucose Spikes After Carbohydrate Consumption.

Conditions
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Tolerance, Side Effect, Glucose Response

Intervention / Treatment
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* Drug: Acarbose Tablets 50mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-85 Any sex Any ethnicity Interest in taking Acarbose off-label Approved by the AgelessRx Medical team to take Acarbose Willing and technically able to use and operate a CGM Own a CGM-compatible phone Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable Adequate cognitive function to be able to give informed consent Exclusion Criteria: Diabetes of any type Taking metformin or any other glucose lowering medication Any uncontrolled endocrine disorder (thyroid, pancreatic, adrenal, etc...) Active malignancy of any kind Clinically relevant renal or kidney disease or dysfunction History of eating disorder Taking any medication, or has any medical condition that might interfere with the action of acarbose of the CGM sensor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: Acarbose Tablets 50mg<br>* Acarbose is an Alpha-glucosidase inhibitor. It is a compound also known under the names Glucobay, Precose, and Prandase. Acarbose is used (with diet and other medications) to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Acarbose works by blocking α- glucosidase, which breaks down starch (aka amylose) into glucose (sugar) into your blood. Slowing food digestion helps keep blood glucose from rising very high after meals.<br>|
| Experimental: Arm B<br> | Drug: Acarbose Tablets 50mg<br>* Acarbose is an Alpha-glucosidase inhibitor. It is a compound also known under the names Glucobay, Precose, and Prandase. Acarbose is used (with diet and other medications) to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Acarbose works by blocking α- glucosidase, which breaks down starch (aka amylose) into glucose (sugar) into your blood. Slowing food digestion helps keep blood glucose from rising very high after meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monophasic glucose response | Blood glucose (mg/dl) response following high carbohydrate intake | 120 minutes per phase, recorded on 4 separate occasions over 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Side Effect | Tolerance of side effect profile (Scale 0 - 10) denoting no side effect at all to intolerable | Recorded on 4 separate occasions over 2 weeks. |