Clinical trial

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.

Name

ALRx006

Description

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

Trial arms

Trial start

2022-08-10

Estimated PCD

2022-10-05

Trial end

2022-10-05

Status

Completed

Phase

Early phase I

Treatment

Acarbose Tablets 50mg

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.

Arms:

Arm A, Arm B

Size

Primary endpoint

Monophasic glucose response

120 minutes per phase, recorded on 4 separate occasions over 2 weeks.

Eligibility criteria

Inclusion Criteria: 1. Age 18-85 2. Any sex 3. Any ethnicity 4. Interest in taking Acarbose off-label 5. Approved by the AgelessRx Medical team to take Acarbose 6. Willing and technically able to use and operate a CGM 7. Own a CGM-compatible phone 8. Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable 9. Adequate cognitive function to be able to give informed consent Exclusion Criteria: 1. Diabetes of any type 2. Taking metformin or any other glucose lowering medication 3. Any uncontrolled endocrine disorder (thyroid, pancreatic, adrenal, etc...) 4. Active malignancy of any kind 5. Clinically relevant renal or kidney disease or dysfunction 6. History of eating disorder 7. Taking any medication, or has any medical condition that might interfere with the action of acarbose of the CGM sensor

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

Updated at

2023-07-27

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication