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Идёт набор NCT04812314

Exercise Effects on Adipose Tissue Structure and Function

Без фазы С лечением Obesity Metabolic Syndrome Metabolic Disease Insulin Resistance

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: Exercise, No exercise.
Кому может быть актуально
Состояния в реестре: Obesity, Metabolic Syndrome, Metabolic Disease, Insulin Resistance. Базовые параметры: 18 лет — 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 →

Обзор

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

Подробное описание

Exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. Expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases.

Overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). The research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain).

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests. After the participant completes the study, the study team will help the participant to lose more weight. Total involvement in the study for each participant will likely be about 8-10 months.

Вмешательства

  • Поведенческое Exercise
    Participants will complete a moderate intensity continuous exercise 4 days/week.
  • Поведенческое No exercise
    Participants will remain sedentary throughout the duration of the study.

Первичные конечные точки

  • Oral Glucose Tolerance Test (OGTT) [Срок оценки: 2 hours]
  • Adipose Tissue Fibrosis [Срок оценки: 30 minutes]
  • Muscle Capillarization [Срок оценки: 30 minutes]
  • Adipose Capillarization [Срок оценки: 30 minutes]
  • Fat Cell Size [Срок оценки: 3 minutes]
Вторичные конечные точки (2)
  • Blood Lipid Profile [Срок оценки: 15 minutes]
  • Blood Pressure [Срок оценки: 10 minutes]

Критерии участия

Критерии включения

  • Age: 18-40
  • Body Mass Index: 27-45 kg/m2
  • No regularly planned exercise/physical activity for at least 6 months
  • Women must have regularly occurring menses and must be premenopausal

Критерии исключения

  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect lipid or glucose metabolism, or inflammation
  • Weight instability ≥ ± 6 pounds in the last 3 months
  • Tobacco or e-cigarette users
  • Women must not be pregnant or actively lactating

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
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT04812314 · HUM00175528

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗