Phase 2
N=8
Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)
Aging
Bottom Line
View on ClinicalTrials.gov: NCT02865499 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change in Microbiome — 0; 0; 0 Operational Taxonomic Unit (OTU)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- acarbose (Drug)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Microbiome |
0; 0; 0 | — |
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.
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT02865499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.