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Идёт набор NCT04613791

Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital

Наблюдательное Obesity

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: Blood test.
Кому может быть актуально
Состояния в реестре: Obesity. Базовые параметры: от 18 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 →

Обзор

Obesity is a multifactorial pathology in which external (lifestyle, environment) and internal (psychological or biological, especially genetic) factors are involved. These are responsible for a positive energy balance. One of the external factors that can intervene in the genesis of obesity is the existence of eating disorders: bulimic hyperphagia. Some teams consider bulimic hyperphagia as a form of addiction. After bariatric surgery, the appearance of new addictions has been observed. In connection with Pr Perney's addictology department, the investigators have observed that some patients under treatment for obesity at the endocrinology department subsequently developed other addictions, in particular misuse of alcohol. The hypotheses of this research are : There appears to be a transfer from eating disorders to substance misuse addiction in post-treatment of obesity, particularly in patients who have undergone bariatric surgery. The misuse of addictive substances most concerned by this transfer of addiction in the post-treatment of obesity, particularly after bariatric surgery, seems to be the misuse of alcohol. This will be the first French cohort study on addictive behaviors in patients undergoing bariatric surgery and the first international study including non-operated obese patients benefiting from medical care alone. This study will improve the multidisciplinary management of these patients by integrating addictologists.

Вмешательства

  • Биопрепарат Blood test
    Collection of epidemio-clinical, biological, radiological and therapeutic patient data. Study samples collected from 154 patients to determine whether a particular immune profile could identify individuals prone to insulin resistance

Первичные конечные точки

  • Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire. [Срок оценки: Day 0]
  • Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire. [Срок оценки: Month 12]
  • Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire. [Срок оценки: Month 24]
  • Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire [Срок оценки: Day 0]
  • Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire [Срок оценки: Month 12]
  • Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire [Срок оценки: Month 24]
Вторичные конечные точки (12)
  • Smoking (tobacco addiction) according to the Fagerström test [Срок оценки: Day 0]
  • Smoking (tobacco addiction) according to the Fagerström test [Срок оценки: Month 12]
  • Smoking (tobacco addiction) according to the Fagerström test [Срок оценки: Month 24]
  • Cannabis addiction [Срок оценки: Day 0]
  • Cannabis addiction [Срок оценки: Month 12]
  • Cannabis addiction [Срок оценки: Month 24]
  • Use of cocaine [Срок оценки: Day 0]
  • Use of cocaine [Срок оценки: Month 12]
  • Use of cocaine [Срок оценки: Month 24]
  • Use of amphetamines [Срок оценки: Day 0]
  • Use of amphetamines [Срок оценки: Month 12]
  • Use of amphetamines [Срок оценки: Month 24]

Критерии участия

  • Patient being managed for the first time at Nîmes University Hospital Obesity Clinic ( complete hospitalization, outpatients' or consultation).
  • Patient being managed for obesity defined by a body mass index (BMI) of 30 kg.m-² or over
  • Patient affiliated to or covered by a health insurance scheme.
  • Adult patient (≥ 18 years).

Критерии исключения

  • Patient with psychiatric disorder reducing capacity for comprehension.
  • Patient in an exclusion period determined by another study.
  • Patient under legal guardianship, tutorship or curatorship.
  • Patient to whom it is impossible to give clear information
  • Patient who is pregnant, about to give birth or breastfeeding.

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
  • CHU de Nimes — Nîmes

Идентификаторы

NCT: NCT04613791 · NIMAO/2019-2/FB-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗