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

NCT02865499 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HSC20120304
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline; 8 weeks and 12 weeks

Study Arms (1)

acarbose

EXPERIMENTAL

all participants will receive acarbose

Drug: acarbose

Interventions

acarbose DRUG

acarbose treatment with meals

acarbose

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UTHSCSA

San Antonio, Texas, 78220, United States

Location

MeSH Terms

Interventions

Acarbose

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Limitations and Caveats

Budgetary restraints

Results Point of Contact

• Title: Dean L. Kellogg, Jr, MD, PhD
• Organization: Univ TX Health Science Center San Antonio

kelloggd@uthscsa.edu

2106175197

Study Officials

• Dean L Kellogg, Jr, MD, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: August 12, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 14, 2019
• Results First Posted: March 14, 2019

Record last verified: 2019-02

Locations

US (1)