Aging
Conditions
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.
Interventions
DRUGacarbose
acarbose treatment with meals
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 95 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acarbose all participants to receive acarbose
acarbose: acarbose treatment with meals | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Baseline | Adverse Event | 1 |
| Baseline | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Acarbose |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Change in Microbiome
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.
Time frame: Baseline; 8 weeks and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acarbose | Change in Microbiome | Baseline Measurement | 0 Operational Taxonomic Unit (OTU) |
| Acarbose | Change in Microbiome | 8 Week Measurement | 0 Operational Taxonomic Unit (OTU) |
| Acarbose | Change in Microbiome | 12 Week Measurment | 0 Operational Taxonomic Unit (OTU) |