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OpenTrials
Completed

NCT Number: NCT05542849

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.

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Key information

Conditions

Tolerance Glucose Response Side Effect

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AgelessRx

Ann Arbor, Michigan, 48104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Monophasic glucose response

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

    Blood glucose (mg/dl) response following high carbohydrate intake

Secondary outcomes

  1. Tolerability of Side Effect

    Time frame: Recorded on 4 separate occasions over 2 weeks.

    Tolerance of side effect profile (Scale 0 - 10) denoting no side effect at all to intolerable

Sponsors and collaborators

Lead sponsor

AgelessRx

Industry

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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