Trial Outcomes & Findings for Study of Acarbose in Longevity (NCT NCT02953093)

Last Updated: 2025-06-24

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

10 weeks

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Acarbose First, Then Placebo Participants will take Acarbose three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks as per protocol). After a two week washout period, participants will take Placebo three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks as per protocol).	Placebo First, Then Acarbose Participants will take Placebo three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks as per Protocol). After a two week washout period, participants will take Acarbose three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks as per Protocol).
First Intervention (10 Weeks) STARTED	14	14
First Intervention (10 Weeks) COMPLETED	10	10
First Intervention (10 Weeks) NOT COMPLETED	4	4
Washout Period (2 Weeks) STARTED	10	10
Washout Period (2 Weeks) COMPLETED	10	10
Washout Period (2 Weeks) NOT COMPLETED	0	0
Second Intervention (10 Weeks) STARTED	10	10
Second Intervention (10 Weeks) COMPLETED	10	10
Second Intervention (10 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acarbose First, Then Placebo n=10 Participants Participants will take Acarbose three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks as per protocol). After a two week washout period, participants will take Placebo three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks as per protocol).	Placebo First, Then Acarbose n=10 Participants Participants will take Placebo three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks as per Protocol). After a two week washout period, participants will take Acarbose three times daily for a total of 10 weeks (titration over 4 weeks, maintenance 6 weeks as per Protocol).	Total n=20 Participants Total of all reporting groups
Age, Customized 60-81 years old	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Sex: Female, Male Female	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Sex: Female, Male Male	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	10 participants n=10 Participants	20 participants n=20 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Acarbose

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Acarbose n=20 participants at risk Participants will take Acarbose three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks as per protocol) either prior to their Placebo regimen or following their Placebo regimen, after a 2-week washout period.	Placebo n=20 participants at risk Participants will take Placebo three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks as per Protocol) either prior to their Acarbose regimen or following their Acarbose regimen, after a 2-week washout period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total	5.0% 1/20 • Number of events 1 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total

Other adverse events

Other adverse events
Measure	Acarbose n=20 participants at risk Participants will take Acarbose three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks as per protocol) either prior to their Placebo regimen or following their Placebo regimen, after a 2-week washout period.	Placebo n=20 participants at risk Participants will take Placebo three times daily for 10 weeks (titration over 4 weeks, maintenance 6 weeks as per Protocol) either prior to their Acarbose regimen or following their Acarbose regimen, after a 2-week washout period.
Musculoskeletal and connective tissue disorders Left Arm Discomfort	5.0% 1/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total	0.00% 0/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total
Musculoskeletal and connective tissue disorders Back Pain	5.0% 1/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total	0.00% 0/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total
Musculoskeletal and connective tissue disorders Gout Flare up	5.0% 1/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total	0.00% 0/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total
Gastrointestinal disorders Abdominal Discomfort	5.0% 1/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total	0.00% 0/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total
Gastrointestinal disorders Flatulence (Increased)	5.0% 1/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total	0.00% 0/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total
Musculoskeletal and connective tissue disorders Mild Fibrosis	0.00% 0/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total	5.0% 1/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total
Vascular disorders Hematoma	0.00% 0/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total	5.0% 1/20 • Up to the time of Visit 5 at 16 weeks, approximately 4 months total

Additional Information

Dr. Nir Barzilai

Albert Einstein College of Medicine

Phone: 718-430-3144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place