Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 70 - 95 |
| Updated: | 3/16/2019 |
| Start Date: | June 2016 |
| End Date: | October 2017 |
Acarbose as a Safe Effective Modulator of Aging Deficits in Geriatric Subjects
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.
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.
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.
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.
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)
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