Меню
Идёт набор NCT06776081

Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function

Без фазы С лечением Obesity Weight Loss

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: Weight loss without pharmacotherapy.
Кому может быть актуально
Состояния в реестре: Obesity, Weight Loss. Базовые параметры: от 40 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Adipocyte-Derived Extracellular Vesicles; Novel Biomarker and Mediator of Obesity-Related Endothelial Dysfunction

Обзор

Changes in adipose tissue biology are now recognized as a key factor underlying the increased risk of metabolic and cardiovascular disease with obesity. Clinical interest in adipocyte-derived extracellular vesicles (Ad-EVs) has intensified due to their potential as circulating biomarkers of adipose tissue health and systemic messengers, regulators and mediators of cardiometabolic health and disease with obesity. The investigators hypothesize that elevated Ad-EVs in adults with obesity will be negatively associated with endothelium-dependent vasodilation. Furthermore, the investigators hypothesize that in adults with obesity, intentional weight loss-induced reduction in circulating Ad-EVs is associated with greater endothelium-dependent vasodilation.

Вмешательства

  • Другое Weight loss without pharmacotherapy
    Adults with obesity participating in the 12-week hypocaloric diet-induced weight loss intervention will be individually counseled by the Clinical and Translational Research Center (CTRC) bionutritionist to consume a hypocaloric diet consistent with current dietary recommendations for weight loss until a 6-10% weight loss is achieved.

Первичные конечные точки

  • Phase 1: Circulating adipocyte-derived extracellular vesicles (Ad-EVs) [Срок оценки: Circulating Ad-EVs will measured during Phase 1 visit 2 which is ~2 weeks from their respective start date.]
  • Phase 2: Circulating adipocyte-derived extracellular vesicles (Ad-EVs) [Срок оценки: Circulating Ad-EVs will be measured during Phase 2 visit 15 which is ~17 weeks from their respective start date.]
  • Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh) [Срок оценки: FBF response to ACh will be measured during Phase 1 and the participant's visit 2 which is ~ 2 weeks from their respective start date.]
  • Phase 2: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh) [Срок оценки: FBF response to ACh will be measured during Phase 2 and the participant's visit 15 which is ~17 weeks from their respective start date.]
  • Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP) [Срок оценки: FBF response to NTP will be measured during Phase 1 and the participant's visit 2 which is ~ 2 weeks from their respective start date.]
  • Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP) [Срок оценки: FBF response to NTP will be measured during Phase 2 and the participant's visit 15 which is ~17 weeks from their respective start date.]

Критерии участия

Критерии включения

  • Age ≥40 years
  • BMI <25 kg/m2 and BMI >25 kg/m2 for Phase 1 and BMI >25 kg/m2 for Phase 2. Rationale for defining obesity as BMI >25 kg/m2

Критерии исключения

  • Current smoker
  • Chronic overt medical condition (e.g., evidence of coronary artery disease on resting ECG, any history of myocardial infarction or stroke, or cancer, diabetes based on fasting blood glucose concentration)
  • Alcohol abuse or dependence defined as more than 14 standard drinks/week and no more than 4 standard drinks/day for men and 7 standard drinks/week and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wines, 1 ½ ounces of 80-proof distilled spirits) reported during the medical history/physical exam
  • Stage III hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg)
  • Regular vigorous aerobic/endurance exercise (>3 bouts/week, >30 minutes/bout at a workload >6 METS)
  • Women who are pregnant or breastfeeding
  • History of anaphylaxis to betadine, lidocaine, iodine
  • Raynaud's disease
  • History of clotting disorders
  • Anyone taking blood thinners and clotting medications
  • Anyone taking statin medication
  • Planned pregnancy in coming 4-6 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Colorado Boulder Clinical and Translational Research Center (CTRC) — Boulder

Идентификаторы

NCT: NCT06776081 · 24-0523 · 24TPA1301309

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗