AgingPhase 2NCT02865499
Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)
A Phase 2 study testing acarbose in people with Aging, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study addresses a "lifespan approach to healthy development and aging" with direct relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot study to: i) better estimate power for a larger trial, ii) establish the safety and potential beneficial effects of acarbose in non-diabetic… Read more about this study
- Who is it for?
- Ages 70 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- acarbose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 70-95
- participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
- participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.
Who cannot join
- unstable ischemic heart disease
- clinically significant pulmonary disease
- history of immunodeficiency or receiving immunosuppressive therapy
- history of a coagulopathy or receiving a medical condition requiring anticoagulation
- an estimated glomerular filtration rate of <30ml/min
- uncontrolled hypercholesteremia >350mg/dl;
Show all 11Show fewer
- uncontrolled hypertriglyceridemia >500mg/dl
- diabetes
- history of skin ulcers or poor wound healing
- smoking
- liver disease treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acarbose as a Safe Effective Modulator of Aging Deficits in Geriatric Subjects
This study addresses a "lifespan approach to healthy development and aging" with direct relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot study to: i) better estimate power for a larger trial, ii) establish the safety and potential beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the effects of acarbose on the microbiome likely play a role in its enhancement of longevity and/or healthy aging. These are essential initial steps for translating acarbose into an anti-aging human therapy.
Read the detailed description
Treatment with acarbose, an α-glucosidase inhibitor, extends median lifespan by 22% in male mice. Acarbose is FDA-approved for use in humans and has been extensively employed for the management of diabetics; there have been few associated side effects reported. Acarbose is considered a very safe treatment. Thus, the investigators hypothesize that acarbose treatment could be used in elderly humans to elicit improvement in systems known to be negatively affected by aging. Since the outcomes of acarbose treatment may be differentially affected by age, it is imperative to test the drug directly in older subjects for its safety and efficacy. Towards this end, the investigators propose to perform a small pilot study assessing the effects of acarbose in ten elderly subjects, aged 75-95 years old. Briefly, a cohort of non-diabetics will be recruited; subjects will be in generally good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable. Trial participants will be studied before drug initiation (pre-treatment), during 3 months of acarbose (blood draws at 1 month and 3 months of treatment), and following termination of the drug (1 and 3 months post treatment) such that each subject will serve as his own control. Gut microbiome composition will be assessed.
- Conditions
- Aging
- Being tested
- acarbose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acarboseDrug
acarbose treatment with meals
| Study group | Role | What they receive |
|---|---|---|
| acarbose | Experimental | all participants will receive acarbose Receives: Drug: acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microbiome
Changes in bacterial community measurement through DNA extraction from stool samples. Change is measured using operational taxonomic units (OTU). An OTU is the group of organisms being studied through DNA to cluster sequences of microbiomes according to their similarity to one another (the similarity threshold is set to 97%). This outcome measures change in the number of OTUs from baseline to 12 weeks.
Measured: Baseline; 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dean L. Kellogg, Jr, The University of Texas Health Science Center at San Antonio
- Investigators
- Dean L Kellogg, Jr, MD, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865499
- Sponsor's protocol ID
- HSC20120304
- Status last verified
- Feb 2019
- First submitted
- 17 Jun 2016
- Last updated
- 14 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acarbose as a Safe Effective Modulator of Aging Deficits in Geriatric Subjects
- ClinicalTrials.gov ID
- NCT02865499
- Acronym / sponsor ID
- HSC20120304
- Conditions
- Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study addresses a "lifespan approach to healthy development and aging" with direct relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot study to: i) better estimate power for a larger trial, ii) establish the safety and potential beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the effects of acarbose on the microbiome likely play a role in its enhancement of longevity and/or healthy aging. These are essential initial steps for translating acarbose into an anti-aging human therapy.
Detailed description
Treatment with acarbose, an α-glucosidase inhibitor, extends median lifespan by 22% in male mice. Acarbose is FDA-approved for use in humans and has been extensively employed for the management of diabetics; there have been few associated side effects reported. Acarbose is considered a very safe treatment. Thus, the investigators hypothesize that acarbose treatment could be used in elderly humans to elicit improvement in systems known to be negatively affected by aging. Since the outcomes of acarbose treatment may be differentially affected by age, it is imperative to test the drug directly in older subjects for its safety and efficacy. Towards this end, the investigators propose to perform a small pilot study assessing the effects of acarbose in ten elderly subjects, aged 75-95 years old. Briefly, a cohort of non-diabetics will be recruited; subjects will be in generally good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable. Trial participants will be studied before drug initiation (pre-treatment), during 3 months of acarbose (blood draws at 1 month and 3 months of treatment), and following termination of the drug (1 and 3 months post treatment) such that each subject will serve as his own control. Gut microbiome composition will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acarbose | Experimental | Drug: acarboseall participants will receive acarbose |
Who may qualify
- Ages
- 70 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age 70-95
- participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
- participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.
Key exclusion criteria (11 listed)
- unstable ischemic heart disease
- clinically significant pulmonary disease
- history of immunodeficiency or receiving immunosuppressive therapy
- history of a coagulopathy or receiving a medical condition requiring anticoagulation
- an estimated glomerular filtration rate of <30ml/min
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 |
|---|---|---|
| acarboseacarbose treatment with meals | Drug | acarbose |
Primary outcome
Change in Microbiome
Time frame: Baseline; 8 weeks and 12 weeks
Changes in bacterial community measurement through DNA extraction from stool samples. Change is measured using operational taxonomic units (OTU). An OTU is the group of organisms being studied through DNA to cluster sequences of microbiomes according to their similarity to one another (the similarity threshold is set to 97%). This outcome measures change in the number of OTUs from baseline to 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dean L Kellogg, Jr, MD, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acarbose in people with Aging, run by The University of Texas Health Science Center at San Antonio 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 3 inclusion and 11 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 14 Mar 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Microbiome (time frame: Baseline; 8 weeks and 12 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 14 Mar 2019.