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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.
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| Name | Class |
|---|---|
| Glenn Foundation for Medical Research | UNKNOWN |
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The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose | Drug | see arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nir F Barzilai, MD | Albert Einstein College of Medicine Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
There is no plan to share individual participant data to researchers who are not part of the study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (10 Weeks) |
| |||||||||||||
| Washout Period (2 Weeks) |
| |||||||||||||
| Second Intervention (10 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was presented using a customized format based on the eligibility criteria and cohort associated with the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | 10 weeks |
Up to the time of Visit 5 at 16 weeks, approximately 4 months total
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acarbose | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (unspecified) | Non-systematic Assessment | Respiratory Tract Neoplasms |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Arm Discomfort | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim Term |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nir Barzilai | Albert Einstein College of Medicine | 718-430-3144 | nir.barzilai@einsteinmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2018 | Mar 3, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2018 | Jan 18, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Placebo | Other | See arm description |
|
| 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. | At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment |
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| NOT COMPLETED |
|
| 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). |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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). |
| OG001 | 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). |
|
| Secondary | 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. | 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. | Posted | At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment |
|
|
| Secondary | 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. | 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. | Posted | At the end of 10 week treatment period (Visit 4) and at 22 weeks (Visit 6) following enrollment |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | Placebo | 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. | 0 | 20 | 1 | 20 | 2 | 20 |
|
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim Term |
|
| Gout Flare up | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim Term |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim Term |
|
| Flatulence (Increased) | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim Term |
|
| Mild Fibrosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim Term: Mild Fibrosis in left periumbilical area |
|
| Hematoma | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim Term: Hematoma in left leg post-biopsy |
|
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