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Идёт набор NCT05000996

Gut Microbiota in Metabolic Surgery

— Наблюдательное Bariatric Surgery Candidate Cardiovascular Diseases Type 2 Diabetes Dyslipidemias

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: Bariatric Surgery.
Кому может быть актуально
Состояния в реестре: Bariatric Surgery Candidate, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidemias. Базовые параметры: 21 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 →

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Официальное название

The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study

Обзор

Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.

Вмешательства

  • Процедура Bariatric Surgery
    Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)

Первичные конечные точки

  • Estimated 10-year risk of atherosclerotic cardiovascular disease [Срок оценки: From before surgery to 1 to 3-year after surgery to 10-year after surgery]
Вторичные конечные точки (4)
  • Glycated hemoglobin [Срок оценки: From before surgery to 1 to 3-year after surgery to 10-year after surgery]
  • Blood pressure [Срок оценки: From before surgery to 1 to 3-year after surgery to 10-year after surgery]
  • Blood cholesterol [Срок оценки: From before surgery to 1 to 3-year after surgery to 10-year after surgery]
  • Blood inflammatory proteins [Срок оценки: From before surgery to 1 to 3-year after surgery to 10-year after surgery]

Критерии участия

Критерии включения

  • Be approved and scheduled for metabolic surgery at the Vanderbilt University Medical Center
  • Have a history of type 2 diabetes, hypertension, or dyslipidemia
  • Be able and willing to provide personal information and biological samples needed for the study

Критерии исключения

  • Prior gastric operations
  • A history of coronary artery disease, stroke, heart failure, HIV infection, or untreated viral hepatitis
  • Chemotherapy or radiotherapy for cancer within 2 years
  • Current inflammatory bowel disease or celiac disease
  • Vomiting, constipation, or diarrhea within 7 days or use of antibiotics within 2 months

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Vanderbilt_University MC — Nashville

Публикации

  • Yu D, Shu XO, Howard EF, Long J, English WJ, Flynn CR. Fecal metagenomics and metabolomics reveal gut microbial changes after bariatric surgery. Surg Obes Relat Dis. 2020 Nov;16(11):1772-1782. doi: 10.1016/j.soard.2020.06.032. Epub 2020 Jun 27. PMID 32747219

Идентификаторы

NCT: NCT05000996 · VUMC_IRB#201652 · R01DK126721

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗