The Efficacy and Tolerability of Acarbose in Healthy Individuals

NCT05542849 | Completed Phase 4 FDA Drug

• 1 other identifier: ALRx006
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tolerance; Side Effect; Glucose Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerability of Side Effect

  Recorded on 4 separate occasions over 2 weeks.

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Acarbose Tablets 50mg

Arm B

EXPERIMENTAL

Drug: Acarbose Tablets 50mg

Interventions

Acarbose Tablets 50mg DRUG

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.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AgelessRx: lead

Study Sites (1)

AgelessRx

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Interventions

Acarbose

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: August 10, 2022
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)