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

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ClinicalTrials.gov Identifier: NCT02865499
Recruitment Status : Completed
First Posted : August 12, 2016
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Dean L. Kellogg, Jr, The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Aging Drug: acarbose Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acarbose as a Safe Effective Modulator of Aging Deficits in Geriatric Subjects
Study Start Date : June 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

Arm Intervention/treatment
Experimental: acarbose
all participants will receive acarbose
Drug: acarbose
acarbose treatment with meals




Primary Outcome Measures :
  1. Change in Microbiome [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 <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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865499


Locations
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United States, Texas
UTHSCSA
San Antonio, Texas, United States, 78220
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Dean L Kellogg, Jr, MD, PhD University of Texas
  Study Documents (Full-Text)

Documents provided by Dean L. Kellogg, Jr, The University of Texas Health Science Center at San Antonio:

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Responsible Party: Dean L. Kellogg, Jr, Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02865499     History of Changes
Other Study ID Numbers: HSC20120304
First Posted: August 12, 2016    Key Record Dates
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs