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SAIL: Study of Acarbose in Longevity

Sponsor
Montefiore Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02953093
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
27.9
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of Changes in Muscle and Fat Gene Transcription With Acarbose Treatment: a Crossover Study
Actual Study Start Date :
Aug 30, 2017
Actual Primary Completion Date :
Apr 20, 2019
Actual Study Completion Date :
Dec 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Acarbose first

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
see arm description
Other Names:
  • Precose

    • Other: Placebo
    See arm description
    Other: Placebo first

    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
    see arm description
    Other Names:
  • Precose

    • Other: Placebo
    See arm description

    Outcome Measures

    Primary Outcome Measures

    1. Tissue gene expression after placebo vs after acarbose. [10 weeks]

      Difference in gene expression in muscle and abdominal adipose tissue (with adjusted p-value less than 0.05, and a fold change greater than 2) using RNA-seq analysis after 10 weeks of acarbose compared to 10 weeks of placebo.

    Secondary Outcome Measures

    1. Serum microRNA [10 weeks]

      Difference in microRNA expression level (with adjusted p <0.05) after 10 weeks of acarbose compared to 10 weeks of placebo.

    2. Fecal microbiome [10 weeks]

      Difference in 16s rDNA gene sequence expression level (with adjusted p <0.05) after 10 weeks of acarbose compared to 10 weeks of placebo.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 100 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Male

    • age >60 years

    • impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)

    Exclusion Criteria:

    • cancer

    • heart failure

    • COPD

    • inflammatory conditions

    • 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.

    • Treatment with anti-coagulant medications or anti-platelet drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montefiore Medical Center Bronx New York United States 10461

    Sponsors and Collaborators

    • Montefiore Medical Center

    Investigators

    • Principal Investigator: Nir F Barzilai, MD, Albert Einstein College of Medicine/ Montefiore Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Nir Barzilai, Professor of Medicine and Genetics, Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT02953093
    Other Study ID Numbers:
    • 2016-6933
    First Posted:
    Nov 2, 2016
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nir Barzilai, Professor of Medicine and Genetics, Montefiore Medical Center
    acarbose
    aging
    Additional relevant MeSH terms:
    Acarbose

    Study Results

    No Results Posted as of Jan 26, 2022