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Study of Acarbose in Longevity (SAIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02953093
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE September 9, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE November 22, 2016
Actual Primary Completion Date December 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
Tissue gene expression after placebo vs after acarbose. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • Serum microRNA [ Time Frame: 10 weeks ]
    Difference in microRNA expression level (with adjusted p <0.05) after 10 weeks of acarbose compared to 10 weeks of placebo.
  • Fecal microbiome [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Acarbose in Longevity
Official Title  ICMJE Study of Changes in Muscle and Fat Gene Transcription With Acarbose Treatment: a Crossover Study
Brief Summary The investigators are studying the effects of acarbose on muscle and adipose gene transcription in older adults.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aging
Intervention  ICMJE
  • Drug: Acarbose
    see arm description
    Other Name: Precose
  • Other: Placebo
    See arm description
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Acarbose
    • Other: Placebo
  • 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).
    Interventions:
    • Drug: Acarbose
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2020)
34
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2016)
30
Actual Study Completion Date  ICMJE December 26, 2019
Actual Primary Completion Date December 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 60 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953093
Other Study ID Numbers  ICMJE 2016-6933
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data to researchers who are not part of the study
Responsible Party Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nir F Barzilai, MD Albert Einstein College of Medicine/ Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP