Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)

Phase 2

Completed

Brief Summary: This study addresses a "lifespan approach to healthy development and aging" with direct relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot study to: i) better estimate power for a larger trial, ii) establish the safety and potential beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the effects of acarbose on the microbiome likely play a role in its enhancement of longevity and/or healthy aging. These are essential initial steps for translating acarbose into an anti-aging human therapy.

Detailed Description: Treatment with acarbose, an α-glucosidase inhibitor, extends median lifespan by 22% in male mice. Acarbose is FDA-approved for use in humans and has been extensively employed for the management of diabetics; there have been few associated side effects reported. Acarbose is considered a very safe treatment. Thus, the investigators hypothesize that acarbose treatment could be used in elderly humans to elicit improvement in systems known to be negatively affected by aging. Since the outcomes of acarbose treatment may be differentially affected by age, it is imperative to test the drug directly in older subjects for its safety and efficacy. Towards this end, the investigators propose to perform a small pilot study assessing the effects of acarbose in ten elderly subjects, aged 75-95 years old. Briefly, a cohort of non-diabetics will be recruited; subjects will be in generally good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable. Trial participants will be studied before drug initiation (pre-treatment), during 3 months of acarbose (blood draws at 1 month and 3 months of treatment), and following termination of the drug (1 and 3 months post treatment) such that each subject will serve as his own control. Gut microbiome composition will be assessed.

Recruitment & Eligibility

Inclusion Criteria

age 70-95
participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

Exclusion Criteria

unstable ischemic heart disease
clinically significant pulmonary disease
history of immunodeficiency or receiving immunosuppressive therapy
history of a coagulopathy or receiving a medical condition requiring anticoagulation
an estimated glomerular filtration rate of <30ml/min
uncontrolled hypercholesteremia >350mg/dl;
uncontrolled hypertriglyceridemia >500mg/dl
diabetes
history of skin ulcers or poor wound healing
smoking
liver disease treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)

Arm && Interventions

Group	Intervention	Description
acarbose	acarbose	all participants will receive acarbose

Primary Outcome Measures

Name	Time	Method
Change in Microbiome	Baseline; 8 weeks and 12 weeks	Changes in bacterial community measurement through DNA extraction from stool samples. Change is measured using operational taxonomic units (OTU). An OTU is the group of organisms being studied through DNA to cluster sequences of microbiomes according to their similarity to one another (the similarity threshold is set to 97%). This outcome measures change in the number of OTUs from baseline to 12 weeks.

Secondary Outcome Measures