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

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Completed
• CT.gov ID: NCT02865499
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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: Jun 1, 2016
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UTHSCSA	San Antonio	Texas	United States	78220

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Dean L Kellogg, Jr, MD, PhD, University of Texas

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 28, 2017

More Information

Publications

None provided.

• Responsible Party: Dean L. Kellogg, Jr, Professor, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02865499
• Other Study ID Numbers: HSC20120304
• First Posted: Aug 12, 2016
• Last Update Posted: Mar 14, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acarbose

Study Results

Participant Flow

Arm/Group Title	Acarbose
Arm/Group Description	all participants will receive acarbose acarbose: acarbose treatment with meals
Period Title: Baseline
STARTED	8
COMPLETED	6
NOT COMPLETED	2
Period Title: Baseline
STARTED	6
COMPLETED	6
NOT COMPLETED	0
Period Title: Baseline
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Acarbose
Arm/Group Description	all participants to receive acarbose acarbose: acarbose treatment with meals
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	6 100%
Sex: Female, Male (Count of Participants)
Female	2 33.3%
Male	4 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 16.7%
Not Hispanic or Latino	5 83.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Microbiome
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acarbose
Arm/Group Description	Stool specimens from all participants analyzed after acarbose
Measure Participants	6
Baseline Measurement	0
8 Week Measurement	0
12 Week Measurment	0

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Acarbose
Arm/Group Description	all participants will receive acarbose acarbose: acarbose treatment with meals
All Cause Mortality
	Acarbose
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	Acarbose
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Acarbose
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/Caveats

Budgetary restraints

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.