Vascular Effects of SGLT2i in Non-diabetic CKD
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Empagliflozin, Placebo.
- Кому может быть актуально
- Состояния в реестре: Non-diabetic Chronic Kidney Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effects of SGLT2 Inhibition on Vascular Health and Physical Function in Veterans With CKD
Обзор
Empagliflozin, a sodium-glucose co-transporter 2 inhibitor (SGLT2i), is a novel diabetic medication that reduces the risk of progression of chronic kidney disease (CKD) and heart failure and improves exercise tolerance regardless of the diabetes status. One of the important ways that empagliflozin improves health may be through its benefits on blood vessels. The effects of empagliflozin on blood vessels and physical function have not been examined in patients with chronic kidney disease, and it is less clear if empagliflozin may be beneficial in patients with chronic kidney disease without heavy urinary protein leakage. The investigators will examine if empagliflozin can improve blood vessel function and exercise tolerance in Veterans with chronic kidney disease without heavy urinary protein leakage.
Подробное описание
Overall Strategy: The investigators propose a randomized, double-blind, placebo-controlled, phase-II study in 52 Veterans with non-diabetic CKD without heavy albuminuria (\<300 mg/g) and eGFR 20-59 mL/min/1.73m2 to investigate if empagliflozin, a selective SGLT2i, can improve vascular function, functional capacity, and plasma biomarkers of inflammation, oxidative stress, and nitric oxide (NO). Veterans will be recruited from the Salt Lake City VA and randomized to 10 mg of empagliflozin or placebo at 1:1 ratio and treated for 16 weeks.
Overarching Hypothesis: SGLT2 inhibition improves endothelial function in both macro- and micro-vasculature, in part, by mitigating inflammation and oxidative stress and augmenting NO bioavailability in patients with CKD, even in the absence of heavy albuminuria. The improved vascular function contributes to increased functional capacity.
Specific Aim 1: Comprehensively evaluate the efficacy of empagliflozin to improve vascular health, as determined by conduit artery endothelium-dependent vasodilation (flow-mediated dilation, FMD), peripheral microvasculature reactivity (passive limb movement, PLM), and arterial stiffness (carotid-femoral pulse wave velocity, PWV), in non-diabetic Veterans with CKD and albuminuria \<300 mg/g.
Specific Aim 2: Evaluate the efficacy of empagliflozin to improve functional capacity using (a) handgrip exercise and (b) mobility tests (Timed Up-and-Go test, gait speeds, and 6-minute walk).
Specific Aim 3 (Exploratory): Evaluate the efficacy of empagliflozin to (a) reduce plasma biomarkers of systemic inflammation (C-reactive protein, interleukin-6, tumor necrosis factor- ) and oxidative stress (free radical concentration assessed by electron paramagnetic resonance spectroscopy) and (b) increase plasma NO, as reflected by plasma nitrite and nitrosyl hemoglobin levels.
Вмешательства
- Препарат Empagliflozin
Empagliflozin 10 mg, encapsulated to match the placebo, will be used. - Препарат Placebo
Matching placebo will be used.
Первичные конечные точки
- Change in endothelium-dependent vasodilation as measured by flow mediated dilation (FMD) [Срок оценки: baseline, 8 weeks, 16 weeks]
Вторичные конечные точки (4)
- Change in leg blood flow area-under-the-curve (LBF AUC) by Passive Leg Movement (PLM) [Срок оценки: baseline, 8 weeks, 16 weeks]
- Changes in aortic stiffness as measured by carotid-femoral pulse wave velocity (PWV) [Срок оценки: baseline, 8 weeks, 16 weeks]
- Changes in functional capacity as measured by handgrip exercise [Срок оценки: baseline, 8 weeks, 16 weeks]
- Mobility [Срок оценки: baseline, 8 weeks, and 16 weeks]
Критерии участия
Критерии включения
- adults aged 18 years of age or older
- eGFR 20-59 mL/min
- albuminuria <300 mg/g
Критерии исключения
- Type 1 or 2 diabetes mellitus
- expected to start dialysis or receive kidney transplantation or die within 4 months
- prior therapy with SGLT2i within the previous year
- unable to participate in the physical function tests (hand grip, walk)
- infections requiring intravenous antibiotic treatment
- malignancy requiring systemic therapy
- extremity skin ulceration requiring active therapy
- history of Fournier's gangrene
- severe hypoglycemia requiring external assistance within the past one year
- known allergy to empagliflozin
- pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City
Идентификаторы
NCT: NCT07060417 · NEPH-006-24F