Empagliflozin Reversal of Arterial StiffnEss in Aging

Description

Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.

Conditions

Aging, Arterial Stiffness

Talk to us

Study Overview

On this page

Study Details

Study overview

Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.

SGLT2 Inhibition as a Therapeutic Strategy to Reverse Arterial Stiffening in Aging

Empagliflozin Reversal of Arterial StiffnEss in Aging

Condition
Aging
Intervention / Treatment

-

Contacts and Locations

Columbia

University of Missouri, Columbia, Missouri, United States, 65211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Able to provide consent
  • * 60 to 80 years of age at randomization (women must be postmenopausal defined as more than 1 year without menses)
  • * Stable anti-hypertensive medication regimen (if in use) for at least 90 days
  • * Evidence of arterial stiffening (defined as carotid-femoral PWV \>/= 8.5 m/s)30,31 at the time of screening visit.
  • * Diabetes
  • * BMI\>/= 45kg/m2
  • * Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
  • * Estimated glomerular filtration rate GFR \< 29 mL/min
  • * Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
  • * Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
  • * Use of hormone replacement therapy
  • * Body weight change ≥10% within the last 6 months
  • * Uncontrolled hypertension during screening visit (\>180/110 mmHg)
  • * Symptomatic hypotension and/or a SBP \<100 mmHg
  • * History of ketoacidosis
  • * High fall risk per assessment of study physician and/or safety officer at the time of screening (results must be abnormal for both fall risk assessments or abnormal orthostatic blood pressure measurements)
  • * Anticipated need of prolonged fasting
  • * History of recurrent UTIs or mycotic genital infections
  • * Following a low-carbohydrate diet (\<20 grams/day)
  • * Participation in regular exercise \> 3 days/week per week at a moderate or vigorous intensity
  • * Known sensitivity to nitrate medications

Ages Eligible for Study

60 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Missouri-Columbia,

Study Record Dates

2029-02-28