Study of Acarbose in Longevity
- Registration Number
- NCT02953093
- Lead Sponsor
- Montefiore Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
- Male
- age >60 years
- impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Acarbose first Placebo 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). Placebo first Placebo 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). Acarbose first Acarbose 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). Placebo first Acarbose 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).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸Bronx, New York, United States