Trial · NCT02953093
Study of Acarbose in Longevity
NCT02953093, Phase 2, Terminated, Montefiore Medical Center; results first posted 2025-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Acarbose in Longevity. Trials, record NCT02953093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02953093
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Acarbose in Longevity
- NCT number
- NCT02953093
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Aging
- Interventions
- Acarbose, Placebo
- First posted
- 2016-11-02
- Last updated
- 2025-06-24
- Results first posted
- 2025-06-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tissue Gene Expression Using RNA Sequencing (RNA-Seq) | 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. |
| Secondary | Serum microRNA (miRNA) | At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment | 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. |
| Secondary | Fecal Microbiome for 16s Ribosomal DNA (rDNA) Gene Sequencing | At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tissue Gene Expression Using RNA Sequencing (RNA-Seq) | 10 weeks | Muscle and abdominal adipose tissue biopsies collected and processed for gene expression data analyses did not yield meaningful data as the results were unable to be differentially expressed and could not be reported. Funding for repeat assays was unavailable and this study was terminated and unable to be published. Funding required to repeat gene expression data analyses is not available and results for this Outcome Measure will never be able to be reported. | ||
| SECONDARY | Serum microRNA (miRNA) | At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment | Serum samples collected and pre-processed for microRNA expression level determinations were never sequenced and analyzed due to lack of funding. Since samples were never sequenced and analyzed there is no read count data to summarize and there are no results to report. Funding to sequence samples for analysis is not available and results for this Outcome Measure will never be able to be reported. | ||
| SECONDARY | Fecal Microbiome for 16s Ribosomal DNA (rDNA) Gene Sequencing | At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment | Stool samples collected for 16S fecal microbiome analysis were submitted to an external laboratory for processing and analysis; however, results were confounding and uninterpretable. As such, relative abundance plots were unable to be generated. In the absence of relative abundance plots there is no gene expression data to review, summarize, or report. Funding required to repeat fecal microbiome analyses is not available and results for this Outcome Measure will never be able to be reported. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (10 Weeks) | STARTED | Acarbose First, Then Placebo | 14 | |
| First Intervention (10 Weeks) | STARTED | Placebo First, Then Acarbose | 14 | |
| First Intervention (10 Weeks) | COMPLETED | Acarbose First, Then Placebo | 10 | |
| First Intervention (10 Weeks) | COMPLETED | Placebo First, Then Acarbose | 10 | |
| First Intervention (10 Weeks) | NOT COMPLETED | Acarbose First, Then Placebo | 4 | |
| First Intervention (10 Weeks) | NOT COMPLETED | Placebo First, Then Acarbose | 4 | |
| Washout Period (2 Weeks) | STARTED | Acarbose First, Then Placebo | 10 | |
| Washout Period (2 Weeks) | STARTED | Placebo First, Then Acarbose | 10 | |
| Washout Period (2 Weeks) | COMPLETED | Acarbose First, Then Placebo | 10 | |
| Washout Period (2 Weeks) | COMPLETED | Placebo First, Then Acarbose | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Left Arm Discomfort | Musculoskeletal and connective tissue disorders | Acarbose | 1 | 20 | |
| other | Left Arm Discomfort | Musculoskeletal and connective tissue disorders | Placebo | 0 | 20 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Acarbose | 1 | 20 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 20 | |
| other | Gout Flare up | Musculoskeletal and connective tissue disorders | Acarbose | 1 | 20 | |
| other | Gout Flare up | Musculoskeletal and connective tissue disorders | Placebo | 0 | 20 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Acarbose | 1 | 20 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo | 0 | 20 | |
| other | Flatulence (Increased) | Gastrointestinal disorders | Acarbose | 1 | 20 | |
| other | Flatulence (Increased) | Gastrointestinal disorders | Placebo | 0 | 20 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acarbose | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Acarbose | 3 | 20 |
| Total, other adverse events | Placebo | 2 | 20 |
| Total, serious adverse events | Acarbose | 0 | 20 |
| Total, serious adverse events | Placebo | 1 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acarbose vs Placebo: deaths from any cause | Trial comparisons |
| Acarbose vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02953093
GET https://conductscience.org/api/trials/v1/NCT02953093/registered