AgingPhase 2SAILNCT02953093
Study of Acarbose in Longevity
A Phase 2 study testing Acarbose in people with Aging, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults. Read more about this study
- Who is it for?
- Ages 60 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Acarbose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 26 Dec 2019
- 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 60 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- age >60 years
- impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)
Who cannot join
- cancer
- heart failure
- Chronic Obstructive Pulmonary Disease (COPD)
- inflammatory conditions
- estimated Glomerular Filtration Rate (eGFR) <45
- active liver disease
Show all 16Show fewer
- poorly controlled hypertension
- epilepsy
- recent cardiovascular disease event (last 6 months)
- inflammatory bowel disease
- history of bariatric or other gastric surgery
- cigarette smoking
- serious substance abuse.
- Treatment with drugs known to influence glucose metabolism
- Hypersensitivity to acarbose or any component of the formulation.
- Treatment with anti-coagulant medications or anti-platelet drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Study of Changes in Muscle and Fat Gene Transcription With Acarbose Treatment: a Crossover Study
The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.
Read the detailed description
Acarbose, an FDA approved drug for the treatment of type 2 diabetes, has known effects on glucose metabolism. Evidence from mice indicates that acarbose may prolong lifespan. In humans, acarbose improves inflammatory markers and reduces cardiovascular events. Consequently, acarbose is of interest in clinical translational aging research since it may influence fundamental processes that contribute to age-related diseases. The study described herein is an exploratory study to examine the effect of acarbose treatment on the biology of aging in humans. Specifically, the investigators plan to study whether treatment with a 10 week course of acarbose will alter the gene expression profile in adipose tissue and muscle in older adults in pathways that are known to be affected by human aging, in a placebo-controlled crossover study.
- Conditions
- Aging
- Being tested
- Acarbose, Placebo
- Keywords
- acarbose, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Also called Precose
see arm description
PlaceboOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Acarbose first | Other | Participants will take acarbose three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks). After a two week washout, participants will take placebo three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks). Receives: Drug: Acarbose; Other: Placebo |
| Placebo first | Other | Participants will take placebo three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks). After a two week washout, participants will take acarbose three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks). Receives: Drug: Acarbose; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Gene Expression Using RNA Sequencing (RNA-Seq)
Difference in gene expression in muscle and abdominal adipose tissue using RNA-Seq were to have been evaluated to assess the effects of absorbed metabolites on tissues. Muscle and adipose are key metabolic tissues that undergo significant age-related changes and play an active role in the pathogenesis of aging. Muscle and abdominal adipose tissue samples were obtained and homogenized with tissue homogenizer. Subsequent mRNA extraction and analysis of gene expression (RNA seq) was conducted using multiplexed 100bp single-end sequencing. Differential expression between samples and after acarbose and after placebo were to have been determined using a negative binomial model approach implemented in the DESeq package. Results were to have been summarized by study arm and subsequently analyzed.
Measured: 10 weeks
Secondary outcomes (2)
Serum microRNA (miRNA)
Differences in miRNA expression between acarbose and placebo arms were to have been evaluated. 1 milliliter (mL) of sera collected from the processing of blood samples will be used for miRNA sequencing. miRNA was extracted from the serum samples using miRNeasy kit in accordance with the manufacturer's protocol and miRNA libraries were prepared. Cel-miR-39 mimic was added to each sample before extraction, for normalization, and sequenced using multiplexed single-end sequencing on an Illumina HiSeq2500. miRNA are small, non-coding RNAs that regulate gene expression at a post-transcriptional level. Due to their stability in blood, changes in expression of circulating miRNA may serve as markers for age-related pathologies and investigators have correlated B-lymphocyte miRNA profiles in the plasma associated with exceptional longevity. Read counts were to have been summarized by study arm and statistically analyzed using a Wilcoxon test to compare miRNA expression levels.
Measured: At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment
Fecal Microbiome for 16s Ribosomal DNA (rDNA) Gene Sequencing
16s rDNA gene sequence expression levels were to have been assessed following the collection of stool samples. A fecal microbiome stool collection kit was provided to participants for self-collection of samples and returned for treatment and analysis. 16s rDNA sequencing was to have been performed to assess bacterial species clustering. Fecal microbial DNA was extracted from the samples and eluted DNA divided into 1 cubic centimeter (cc) aliquots and shipped for 16s rDNA sequencing. The raw 16s sequence data was converted to taxonomic profiles by grouping 16s sequences into Operational Taxonomic Units (OTUs) based on sequence similarity as well as by generating de-novo OTU generation using a de novo OTU-picking tool. A Basic Local Alignment Search Tool (BLAST) was to have been used to analyze each OTU's representative against a database. Relative abundance plots for visual comparison of microbial abundances were to have been generated, summarized, and reported by study arm.
Measured: At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start30 Aug 2017
- Primary completion20 Apr 2019
- Study completion26 Dec 2019
Why it stopped: Upon review it was determined that the study terminated early due to lack of funding. Study never reached enrollment target and was administratively closed out by the Albert Einstein College of Medicine IRB.
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 Montefiore Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Glenn Foundation for Medical Research
- Responsible party
- Sponsor
- Investigators
- Nir F Barzilai, MD, Principal investigator, Albert Einstein College of Medicine Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953093
- Sponsor's protocol ID
- 2016-6933
- Acronym
- SAIL
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2016
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data to researchers who are not part of the study
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Changes in Muscle and Fat Gene Transcription With Acarbose Treatment: a Crossover Study
- ClinicalTrials.gov ID
- NCT02953093
- Acronym / sponsor ID
- SAIL / 2016-6933
- Conditions
- Aging
- Keywords
- acarbose, aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Upon review it was determined that the study terminated early due to lack of funding. Study never reached enrollment target and was administratively closed out by the Albert Einstein College of Medicine IRB.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Glenn Foundation for Medical Research
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.
Detailed description
Acarbose, an FDA approved drug for the treatment of type 2 diabetes, has known effects on glucose metabolism. Evidence from mice indicates that acarbose may prolong lifespan. In humans, acarbose improves inflammatory markers and reduces cardiovascular events. Consequently, acarbose is of interest in clinical translational aging research since it may influence fundamental processes that contribute to age-related diseases. The study described herein is an exploratory study to examine the effect of acarbose treatment on the biology of aging in humans. Specifically, the investigators plan to study whether treatment with a 10 week course of acarbose will alter the gene expression profile in adipose tissue and muscle in older adults in pathways that are known to be affected by human aging, in a placebo-controlled crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acarbose first | Other | Drug: Acarbose, Other: PlaceboParticipants will take acarbose three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks). After a two week washout, participants will take placebo three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks). |
| Placebo first | Other | Drug: Acarbose, Other: PlaceboParticipants will take placebo three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks). After a two week washout, participants will take acarbose three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks). |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- age >60 years
- impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)
Key exclusion criteria (16 listed)
- cancer
- heart failure
- Chronic Obstructive Pulmonary Disease (COPD)
- inflammatory conditions
- estimated Glomerular Filtration Rate (eGFR) <45
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 |
|---|---|---|
| AcarboseAlso: Precosesee arm description | Drug | Acarbose first, Placebo first |
| PlaceboSee arm description | Other | Acarbose first, Placebo first |
Primary outcome
Tissue Gene Expression Using RNA Sequencing (RNA-Seq)
Time frame: 10 weeks
Difference in gene expression in muscle and abdominal adipose tissue using RNA-Seq were to have been evaluated to assess the effects of absorbed metabolites on tissues. Muscle and adipose are key metabolic tissues that undergo significant age-related changes and play an active role in the pathogenesis of aging. Muscle and abdominal adipose tissue samples were obtained and homogenized with tissue homogenizer. Subsequent mRNA extraction and analysis of gene expression (RNA seq) was conducted using multiplexed 100bp single-end sequencing. Differential expression between samples and after acarbose and after placebo were to have been determined using a negative binomial model approach implemented in the DESeq package. Results were to have been summarized by study arm and subsequently analyzed.
2 secondary outcomes
Serum microRNA (miRNA)
Time frame: At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment
Fecal Microbiome for 16s Ribosomal DNA (rDNA) Gene Sequencing
Time frame: At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to researchers who are not part of the study
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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.
Nir F Barzilai, MD principal investigator
Albert Einstein College of Medicine Montefiore Medical Center
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 Montefiore Medical Center 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 16 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: stopped early, as of the sponsor's last update on 24 Jun 2025. 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 24 Jun 2025). 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?
Tissue Gene Expression Using RNA Sequencing (RNA-Seq) (time frame: 10 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 24 Jun 2025.