Study of Acarbose in Longevity

NCT02953093 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2016-6933
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.

Conditions

Aging

Keywords

acarbose; aging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Serum microRNA (miRNA)

  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

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

Study Arms (2)

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).

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).

Drug: Acarbose; Other: Placebo

Interventions

Acarbose DRUG

see arm description

Also known as: Precose

Acarbose first; Placebo first

Placebo OTHER

See arm description

Acarbose first; Placebo first

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• age \>60 years
• impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)

You may not qualify if:

• cancer
• heart failure
• Chronic Obstructive Pulmonary Disease (COPD)
• inflammatory conditions
• estimated Glomerular Filtration Rate (eGFR) \<45
• active liver disease
• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Glenn Foundation for Medical Research: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

Acarbose

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Nir Barzilai
• Organization: Albert Einstein College of Medicine

nir.barzilai@einsteinmed.edu

718-430-3144

Study Officials

• Nir F Barzilai, MD

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: November 2, 2016
• Study Start: August 30, 2017
• Primary Completion: April 20, 2019
• Study Completion: December 26, 2019
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)