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Идёт набор NCT02861781

Collection of Human Metabolic Tissues

— Наблюдательное Obesity Insulin Resistance Diabetes Mellitus, Type 2

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: Collection of blood samples and tissues.
Кому может быть актуально
Состояния в реестре: Obesity, Insulin Resistance, Diabetes Mellitus, Type 2. 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
Франция
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

Study of New Determinants of Type 2 Diabetes in Severe Obesity

Обзор

This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric surgery in obese patients. Three different groups of metabolic status of patients, corresponding to different stages of evolution of the disease, will be constituted: type 2 diabetes, insulin resistance, insulin sensitivity. The main objective is to compare, between these 3 groups of patients, several biological processes that may be involved in the pathophysiology of type 2 diabetes and disorders associated with obesity, including: * Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma, serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver) * Identification of metabolic signatures, protein and miRNA in plasma * Immunoinflammatory response in adipose tissue * Polymorphisms SNP from whole blood * Histological analysis of tissue sections This main objective will be studied on samples taken at the time of surgery Secondary objectives will be to study the changes in metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of surgery, according to the initial metabolic state.

Вмешательства

  • Другое Collection of blood samples and tissues
    Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits

Первичные конечные точки

  • comparison of metabolites [Срок оценки: At baseline (day of surgery)]
  • comparison of proteins levels [Срок оценки: At baseline (day of surgery)]
  • comparison of miRNA [Срок оценки: At baseline (day of surgery)]
Вторичные конечные точки (3)
  • changes in metabolites in plasma level [Срок оценки: 3 and 12 months after the completion of surgery]
  • changes in proteins in plasma level [Срок оценки: 3 and 12 months after the completion of surgery]
  • changes in miRNA in plasma level [Срок оценки: 3 and 12 months after the completion of surgery]

Критерии участия

Критерии включения

  • Written informed consent
  • Age 18 - 65 years inclusive at surgery
  • IMC > 35
  • Subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)
  • Specific criteria :
  • Type 2 diabetes group (D) (90 patients) : type 2 diabetes according to ADA criteria
  • Insulin resistance non diabetes group (IR) (80 patients) : HOMA-IR criteria ≥ 3
  • Insulin Sensitivity non diabetes group (N) (100 patients) : N1.HOMA-IR criteria < 3

Non inclusion Criteria:

  • Vulnerability according to article L1121-6 of the Public Health Code
  • Protected adult or unability to give consent according to article L1121-8 of the Public Health Code
  • Unability to understand the design and aims of the study or to communicate with the investigator
  • Non affiliation to a social security system
  • Prior bariatric surgery (except lap-band procedure)
  • Serologic profile indicating hepatitis B, hepatitis C or HIV infection
  • Inflammatory, infectious or autoimmune disease (current or in the previous 3 month)
  • Malignancies within 5 years prior to inclusion or not considered as treated curatively
  • Concomitant use of steroids or NSAI or use in the 8 days before surgery
  • alcohol abuse/addiction
  • Anticipated poor compliance to study procedures
  • Other type of diabetes than type 2

Критерии исключения

  • Cancelled bariatric surgery
  • Tissue collection not possible during the bariatric surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital Saint Eloi — Montpellier

Публикации

  • Riviere B, Jaussent A, Macioce V, Faure S, Builles N, Lefebvre P, Geraud P, Picot MC, Rebuffat S, Renard E, Paradis V, Servais MD, de Preville N, Nocca D, Lajoix AD, Pageaux GP, Galtier F; COMET study group. The triglycerides and glucose (TyG) index: A new marker associated with nonalcoholic steatohepatitis (NASH) in obese patients. Diabetes Metab. 2022 Jul;48(4):101345. doi: 10.1016/j.diabet.2022 PMID 35339664

Идентификаторы

NCT: NCT02861781 · RECHMPL15_0271 · 2015-A01193-46 · UF 9605

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗