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Study of Acarbose in Longevity (SAIL)

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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

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
Aging Drug: Acarbose Other: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 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 : November 22, 2016
Actual Primary Completion Date : December 26, 2019
Actual Study Completion Date : December 26, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

Arm Intervention/treatment
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 Name: Precose

Other: Placebo
See arm description

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 Name: Precose

Other: Placebo
See arm description




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953093


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Nir F Barzilai, MD Albert Einstein College of Medicine/ Montefiore Medical Center
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02953093    
Other Study ID Numbers: 2016-6933
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
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
Keywords provided by Montefiore Medical Center:
acarbose
aging
Additional relevant MeSH terms:
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Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs