Purpose

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

Condition

Eligibility

Eligible Ages
Between 60 Years and 100 Years
Eligible Genders
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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461
Contact:
Erika F Brutsaert, MD, MPH
866-633-8255

More Details

NCT ID
NCT02953093
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Erika F Brutsaert, MD
7188397961
erika.brutsaert@einstein.yu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.