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New treatment option for Aging
Official title Empagliflozin Reversal of Arterial StiffnEss in Aging
ClinicalTrials.gov ID: NCT06506422
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for aging.
Also referred to as Active.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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 m/s) at the time of screening visit.
You likely can't join if
- 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)
See the full 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 m/s) 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 and 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.