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Идёт набор NCT01129297

A Biological Atlas of Severe Obesity (Biological Tissue Collection)

— Наблюдательное Obesity Glucose Intolerance Diabetes

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: Obesity, Glucose Intolerance, Diabetes. 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

Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)

Обзор

Type 2 diabetes and obesity are both multifactorial diseases resulting from gene-environment interactions. However, this interaction, as well as the specific effect of each polymorphism, remains poorly understood. We now proposed a prospective cohort study to improve our understanding of the influence of phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid metabolism by collecting different biological samples.

Подробное описание

Type 2 diabetes (T2D) is a disease commonly associated with obesity, which is an important risk factor for this condition. More than 80% of the diabetic subjects are obese. By analogy with the metabolic syndrome, the close association between obesity and T2D justifies the recognition of a new disease entity named by the neologism "diabesity".

This study will examine the contribution of different genetic variants on "diabesity" development, by integrating multiple genomics approaches (linkage analysis on whole genome, transcriptomics and bioinformatics) and analysis of biological pathways in relevant animals models and humans.

Первичные конечные точки

  • Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism [Срок оценки: Baseline]
Вторичные конечные точки (7)
  • Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) [Срок оценки: 1 year]
  • Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) [Срок оценки: 2 years]
  • Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) [Срок оценки: 5 years]
  • Prospective assessment of clinical and biological features before and after bariatric surgery [Срок оценки: 1 year]
  • Prospective assessment of clinical and biological features before and after bariatric surgery [Срок оценки: 2 years]
  • Prospective assessment of clinical ans biological features before and after bariatric surgery [Срок оценки: 5 years]
  • Genotype-Phenotype correlation [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Indication of abdominal surgery requiring a laparotomy or laparoscopy for bariatric surgery, cholecystectomy, or parietal surgical
  • Phenotype corresponding to one of the following four cases :
  • Body Mass Index ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
  • Body Mass Index ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose> 6 mmol/L and <7 mmol/l and/or> 7.8 mmol/l and <11.1 mmol/l , 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
  • Body Mass Index ≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
  • Body Mass Index <27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)

5)27 <Body Mass Index <35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)

Критерии исключения

  • unable to receive clear information
  • refusal to sign the consent form
  • pathology associated judged by the surgeon, may increase the risk of adverse events related to sampling tissue

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Lille University Hospital — Lille

Публикации

  • Lien F, Berthier A, Bouchaert E, Gheeraert C, Alexandre J, Porez G, Prawitt J, Dehondt H, Ploton M, Colin S, Lucas A, Patrice A, Pattou F, Diemer H, Van Dorsselaer A, Rachez C, Kamilic J, Groen AK, Staels B, Lefebvre P. Metformin interferes with bile acid homeostasis through AMPK-FXR crosstalk. J Clin Invest. 2014 Mar;124(3):1037-51. doi: 10.1172/JCI68815. Epub 2014 Feb 17. PMID 24531544
  • Raverdy V, Chatelain E, Lasailly G, Caiazzo R, Vandel J, Verkindt H, Marciniak C, Legendre B, Bauvin P, Oukhouya-Daoud N, Baud G, Chetboun M, Vantyghem MC, Gnemmi V, Leteurtre E, Staels B, Lefebvre P, Mathurin P, Marot G, Pattou F. Combining diabetes, sex, and menopause as meaningful clinical features associated with NASH and liver fibrosis in individuals with class II and III obesity: A retrospec PMID 37987186
  • Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development PMID 37652841
  • Margerie D, Lefebvre P, Raverdy V, Schwahn U, Ruetten H, Larsen P, Duhamel A, Labreuche J, Thuillier D, Derudas B, Gheeraert C, Dehondt H, Dhalluin Q, Alexandre J, Caiazzo R, Nesslany P, Verkindt H, Pattou F, Staels B. Hepatic transcriptomic signatures of statin treatment are associated with impaired glucose homeostasis in severely obese patients. BMC Med Genomics. 2019 Jun 3;12(1):80. doi: 10.118 PMID 31159817

Идентификаторы

NCT: NCT01129297 · 2006_0620 · DGS 2006/0307

Первоисточники (государственные реестры)

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