Меню
Идёт набор NCT07178704

The Metabolic and Genetic Drivers of Body Composition Changes Following Weight Loss Surgery

— Наблюдательное Bariatric Surgery Patients

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Bariatric Surgery Patients. Базовые параметры: 18 лет — 65 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

PILOT STUDY: The Metabolic and Genetic Drivers of Body Composition Changes Following Weight Loss Surgery

Обзор

Weight loss surgery is very good at reducing body weight but it can also cause the loss of both muscle and strength. Some patients undergoing weight loss surgery do not achieve their weight loss goals and regain the weight they lost. When this occurs, the loss of muscle and strength combined with the regain of weight can impact the individual's quality of life and ability to remain active and mobile. The purpose of this study is to understand the behavioral, biological, and genetic factors that influence the success of weight loss surgery and its impact on muscle mass. Bariatric surgery patients participating in the trial will be monitored prior to, and for a year following weight loss surgery, with data collected about their eating habits, hand grip strength, and the loss of fat, muscle, and body weight following surgery. In patients who undergo a routine endoscopy in advance of weight loss surgery a small sample of gut tissue will be collected to identify the expression (activity) of genes in their DNA.

Первичные конечные точки

  • Body composition [Срок оценки: Measured at baseline in both healthy volunteers & bariatric surgery patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.]
Вторичные конечные точки (5)
  • Dietary Protein Intake [Срок оценки: Measured at baseline in both healthy volunteers & patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.]
  • Body weight [Срок оценки: Measured at baseline in both healthy volunteers & bariatric surgery patients. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.]
  • Association between foregut gene expression and degree of weight reduction [Срок оценки: A single occasion from tissue collected during the routine pre-operative upper endoscopy. (baseline)]
  • Handgrip Strength [Срок оценки: Measured at baseline in both healthy volunteers & bariatric surgery patients. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.]
  • Energy Intake [Срок оценки: Measured at baseline in both healthy volunteers & bariatric surgery patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.]

Критерии участия

Inclusion Criteria (Bariatric Surgery Patients):

  • Age: 18 to 65 years at time of consent
  • BMI: 35-65 kg.m-2
  • Scheduled to undergo bariatric surgery at UTMB
  • All races and ethnic backgrounds
  • Ability to speak and read English
  • Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.

Exclusion Criteria (Bariatric Surgery Patients):

  • Fails the medical criteria for bariatric surgery.
  • Anemia (hematocrit < 33 % or donated blood in the past 12 weeks.)
  • Recent (5 years or less) history of cancer
  • Systemic steroids or immunosuppressant use for 8 or more consecutive days in the past 6 months, or any use of anabolic steroids or growth hormones in the same period.
  • Body mass index < 35 or > 65 kg.m-2.
  • Acute infectious disease or chronic infection.
  • Pregnancy or breast-feeding.
  • Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
  • History of prior non-compliance that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigator's instructions.
  • Concurrent participation in another research study.
  • Use of an investigational agent in the 30 days prior to signing informed consent.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • The University of Texas Medical Branch — Galveston

Идентификаторы

NCT: NCT07178704 · 24-0361

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗