The Efficacy and Tolerability of Acarbose in Healthy Individuals

Tolerance Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05542849
• Other study ID #: ALRx006
• Status: Completed
• Phase: Phase 4
• Start date: August 10, 2022
• Est. completion date: October 5, 2022

Study information

• Verified date: July 2023
• Source: AgelessRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Response
• Side Effect
• Tolerance

Intervention

Drug:
• 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 a- 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.

Locations

Country	Name	City	State
United States	AgelessRx	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AgelessRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.