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Идёт набор NCT04583514

Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

Без фазы С лечением Overweight and Obesity Metabolic Syndrome

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: Control, Overfeeding.
Кому может быть актуально
Состояния в реестре: Overweight and Obesity, Metabolic Syndrome. Базовые параметры: 18 лет — 42 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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Обзор

Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.

Вмешательства

  • Поведенческое Control
    Weight-stable Control group
  • Поведенческое Overfeeding
    30% Overfeeding group

Первичные конечные точки

  • Adipose tissue expansion and remodeling -- in vivo adipocyte formation [Срок оценки: 8 weeks]
Вторичные конечные точки (2)
  • Adipose tissue expansion and remodeling -- in vivo triglyceride synthesis [Срок оценки: 8 weeks]
  • Cardiometabolic health outcomes [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Men and pre-menopausal women
  • 18-42 years of age
  • BMI 23-35 kg/m2 (± 0.5 will be accepted)
  • Are willing to drink deuterium-labeled water (2H2O) for 8 weeks
  • Are willing to be randomized to either a CTL or 30% OF group
  • For women, if not using pharmaceutical (hormonal) contraception (i.e. birth control pills, vaginal ring, injections, or implant), must agree to use either a double barrier method as a form of birth control to prevent pregnancy (i.e. male condom with spermicide, with or without cervical cap or diaphragm); use implants or intrauterine contraceptive devices; have a tubal ligation (surgically sterile); practice abstinence; or be in an established relationship with a vasectomized or same sex partner during the entire duration of the study
  • Must be willing to adhere to all study procedures, including attendance at all study visits
  • If enrolled, agree to maintain the same level of physical activity throughout the duration of the study
  • Must be willing to have blood stored for future research

Критерии исключения

  • Unstable weight in the last 3 months (± \~5% weight change)
  • Diagnosis of Type 1 or 2 diabetes or a fasting blood glucose > 110 mg/dL
  • Average screening blood pressure > 140/90 mmHg
  • Diagnosis of major organ disease (e.g. heart, kidney, lung, thyroid, liver disease) or abnormal liver enzymes that are, in the opinion of the MI, clinically significant and represent a problem for study inclusion.
  • Self-reported positive test for human immunodeficiency virus, hepatitis B or hepatitis C
  • Any current or previous eating disorders
  • Chronic use of systemic glucocorticoids (steroids), systemic adrenergic-stimulating agents, beta-blockers, antipsychotic medications, thiazolidinediones and other medications that may cause clinically significant weight gain or loss)
  • Chronic use of prescription weight loss medications or over the counter weight loss medications which, in the opinion of the MI, will impact the study
  • Chronic use of anti-depressant medications for less than 3 months
  • Chronic smokers or users of tobacco products who cannot abstain for the duration of the inpatient visits
  • Previous bariatric or other surgeries for obesity
  • Had cancer in the last 5 years (some skin cancers acceptable)
  • Pregnancy, breastfeeding, or planned pregnancy for the upcoming 6 months
  • Partial or full hysterectomy
  • PCOS
  • Diagnosed psychotic conditions.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Pennington Biomedical Research Center — Baton Rouge

Идентификаторы

NCT: NCT04583514 · PBRC 2019-051 · R01DK121944

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗