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Идёт набор NCT07402031

Predicting Weight Loss After Pharmacological or Surgical Treatment in Patients With Obesity

— Наблюдательное Obesity & Overweight

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: Pharmacological or surgical treament of obesity.
Кому может быть актуально
Состояния в реестре: Obesity & Overweight. 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
Бельгия
Следующий шаг
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Официальное название

Research of Predictive Factors of Weight Loss After Pharmacological or Surgical Treatment in Patients Suffering From Obesity

Обзор

As with other nutritional strategies, the clinical response to bariatric surgery can be highly variable, with weight regain being a frequent occurrence. Recent evidence on anti-obesity medication indicate similar inter-individual variability in clinical response. Among multiples factors, co-occurrence of eating disorders such as binge eating disorder has been implicated in insufficient clinical response. Improving our ability to predict how patients will respond to obesity treatment is necessary in order to tailor the care pathways we offer. The mechanisms involved in disturbances of eating behaviour before and after surgery remain largely unknown. This study aims to identify the predictive factors of weight loss after pharmacological or surgical treatment, as well as the cognitive and biological mechanisms that mediate this effect.

Вмешательства

  • Процедура Pharmacological or surgical treament of obesity
    Longitudinal follow-up of participants who initiate an anti-obesity medication or whose application for bariatric surgery was accepted. It will combine anthropometric, clinical, neuropsychological and biological measurements taken at various timepoints. Participants will be asked to complete a set of online questionnaires and data will be recorded anonymously. Biological samples will be collected at various time points.

Первичные конечные точки

  • Correlation between weight loss after treatment and clinical, neuropsychological and biological parameters. [Срок оценки: Throughout the entire study, aproximately during 5 years]
Вторичные конечные точки (11)
  • Binge Eating Disorder. [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Food Addiction. [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Eating attitudes [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Cognitive flexibility. [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Impulsivity. [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Self-reported quality of life. [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Obesity. [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Physical activity. [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Food intake. [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Blood samples [Срок оценки: Throughout the entire study, aproximately during 5 years]
  • Fecal sample [Срок оценки: Throughout the entire study, aproximately during 5 years]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Obesity, with bariatric surgery indicated after a multidisciplinary evaluation in case of surgical treatment.
  • Good physical and mental health, enabling informed consent.
  • French speaker

Критерии исключения

  • Legal protection
  • Pregnancy or breastfeeding
  • History of bariatric surgery (except gastric banding, provided it was removed more than five years ago).
  • Acute or progressive chronic disease
  • Alcohol consumption of more than 20 g/day
  • Inflammatory bowel disease;
  • Digestive autonomic diabetic neuropathy.
  • Consumption of dietary supplements (stanols, probiotics, prebiotics or omega-3).
  • Following a vegan or gluten-free diet or being lactose intolerant.
  • Fibre consumption >30 g/day
  • Recent change in antidiabetic medication within the past 3 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

Бельгия · 1 центр
  • Cliniques Universitaires Saint-Luc — Brussels

Идентификаторы

NCT: NCT07402031 · TCAPrediBaria

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗