The Efficacy and Tolerability of Acarbose in Healthy Individuals

Phase 4

Completed

• Conditions: Tolerance; Glucose Response; Side Effect
• Interventions: Drug: Acarbose Tablets 50mg

• Registration Number: NCT05542849
• Lead Sponsor: AgelessRx

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-10
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Primary Completion: 2022-10-05
• Study Completion: 2022-10-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Acarbose Tablets 50mg	-
Arm A	Acarbose Tablets 50mg	-

Primary Outcome Measures

Name	Time	Method
Monophasic glucose response	120 minutes per phase, recorded on 4 separate occasions over 2 weeks.	Blood glucose (mg/dl) response following high carbohydrate intake

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AgelessRx; 🇺🇸 Ann Arbor, Michigan, United States