TolerancePhase 4NCT05542849
The Efficacy and Tolerability of Acarbose in Healthy Individuals
A Phase 4 study testing Acarbose Tablets 50mg in people with Tolerance and Side Effect, run by AgelessRx at 1 site in United States.
Trial summary
A Prospective Trial for Acarbose in Healthy Individuals Assessing Safety and Efficacy in Reducing Glucose Spikes After Carbohydrate Consumption. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Tolerance, Side Effect, Glucose Response
- What is being tested?
- Acarbose Tablets 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2022to 5 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Acarbose Tablets 50mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acarbose Tablets 50mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Acarbose Tablets 50mg |
| Arm B | Experimental | Not described Receives: Drug: Acarbose Tablets 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monophasic glucose response
Blood glucose (mg/dl) response following high carbohydrate intake
Measured: 120 minutes per phase, recorded on 4 separate occasions over 2 weeks.
Secondary outcomes (1)
Tolerability of Side Effect
Tolerance of side effect profile (Scale 0 - 10) denoting no side effect at all to intolerable
Measured: Recorded on 4 separate occasions over 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start10 Aug 2022
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgelessRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542849
- Sponsor's protocol ID
- ALRx006
- Status last verified
- Jul 2023
- First submitted
- 14 Sep 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05542849
- Acronym / sponsor ID
- ALRx006
- Conditions
- Tolerance, Side Effect, Glucose Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AgelessRxIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective Trial for Acarbose in Healthy Individuals Assessing Safety and Efficacy in Reducing Glucose Spikes After Carbohydrate Consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Acarbose Tablets 50mg |
| Arm B | Experimental | Drug: Acarbose Tablets 50mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-85
- Any sex
- Any ethnicity
- Interest in taking Acarbose off-label
- Approved by the AgelessRx Medical team to take Acarbose
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acarbose Tablets 50mgAcarbose 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. | Drug | Arm A, Arm B |
Primary outcome
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
1 secondary outcome
Tolerability of Side Effect
Time frame: Recorded on 4 separate occasions over 2 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acarbose Tablets 50mg in people with Tolerance and Side Effect, run by AgelessRx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monophasic glucose response (time frame: 120 minutes per phase, recorded on 4 separate occasions over 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.