RECRUITING

Empagliflozin Reversal of Arterial StiffnEss in Aging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-18

Study Completion:2029-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06506422

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.

Ages Eligible for Study:60 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Camila Manrique, MD

CONTACT

(573) 882-2554

manriquec@health.missouri.edu

Andrea Atkins, BSN

CONTACT

(573) 884-1222

wiesa@health.missouri.edu

Study Locations (Sites)

University of Missouri

Columbia, Missouri, 65211

United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-18

Study Completion Date2029-02-28

Study Record Updates

Study Start Date2024-08-18

Study Completion Date2029-02-28

Terms related to this study

Additional Relevant MeSH Terms

Aging
Arterial Stiffness