Меню
Идёт набор NCT07565051

Can Pre-operative Lean Mass Predict Weight Loss After Roux-en-Y Gastric Bypass?

Наблюдательное Morbid Obesity Requiring Bariatric Surgery

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: Morbid Obesity Requiring Bariatric Surgery. Базовые параметры: Без ограничений · 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this observational study is to evaluate whether preoperative fat-free mass predicts post-operative weight loss in patients undergoing Roux-En-Y gastric bypass. The primary objective of this study is to evaluate whether preoperative fat-free mass predicts weight loss in the two years following RYGB. The investigators will collect the following data, assessed as part of routine follow-up: * height, weight, hip and waist circumferences * body composition by bioimpedance analysis and dual energy-X-ray absorptiometry * Muscle strength and physical activity * Nutritional parameters: resting energy expenditure, eating behavior and digestive tolerance", plasma micronutrient status. . * Cardiovascular risk factors: fasting glucose, blood levels of Hb1Ac, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, blood pressure * Co-morbidities: joint pain and arthritis, sleep apnea, gastro-oesophageal reflux, metabolic dysfunction-associated fatty liver disease (MAFLD), cancer, stroke, heart attack. Quality of life: quality of life by the "Bariatric Analysis and Reporting Outcome (BAROS) questionnaire", symptoms of dumping syndrome by the "Sigstad diagnostic score system" Birthdate, birthweight and term of their children

Подробное описание

This study is prospective but the investigators will also use the retrospective data of the patients who underwent bariatric surgery before the acceptance of the study, with their informed consent.

The investigators will collect the following data, assessed as part of routine follow-up:

Preoperatively:

* medical history * height, weight, hip and waist circumferences * body composition by bioimpedance analysis (BIA) and dual energy-X-ray absorptiometry (DXA) * handgrip strength * sarcopenia questionnaire (SARC-F) * physical activity questionnaire (IPAQ) * resting energy expenditure by indirect calorimetry * eating behaviour: duration of meals, hyperphagia, snacking, compulsions, and cognitive restrictions as variables dichotomized as yes or no, and hunger and satiety each through a visual analogue scale, where 0 corresponds to "no hunger or good satiety" and 10 to "big hunger or no satiety" * digestion symptoms: frequency of vomiting and of bowel movements * Binge eating questionnaire * blood pressure * blood sample * co-morbidities * results of liver ultrasound, gastric endoscopy * quality of life questionnaire (BAROS), Dumping questionnaire (Sigstad) * blood and tissue biobanking

These assessments will be repeated after surgery at the frequency indicated below:

* at month 1: all tests except DXA, sarcopenia questionnaire (SARC-F), physical activty assessment (IPAC), binge eating questionnaire, liver ultrasound and gastric endoscopy, quality of life and dumping questionnaire, blood and tissue biobank * At month 3: all tests except DXA, binge eating questionnaire, dumping, questionnaire, and only if indicated for clinical routine, liver ultrasound and gastric endoscopy. * At month 6: all tests except DXA, sarcopenia questionnaire (SARC-F), physical activty assessment (IPAC), binge eating questionnaire, quality of life questionnaire, and only if indicated for clinical routine, liver ultrasound and gastric endoscopy, only if indicated in clinical routine, blood and tissue biobank. * At year 1, 2, 3, 4 and 5: all tests except liver ultrasound and gastric endoscopy only if indicated in clinical routine * At year 1.5: all tests except DXA, sarcopenia questionnaire (SARC-F), blood and tissue biobank

Study sample calculation:

The investigators hypothesized, in a conservative way and based on available litterature, that the patients will decrease their lean mass by 5±10 kg within 2 years after RYGB. A sample size of 32 achieves 90% power to detect a mean of paired differences of 5 kg with an estimated standard deviation of paired differences of 10.0 and with a significance level (alpha) of 0.050 using a two-sided paired t-test.

The investigators plan to evaluate whether preoperative FFM (independent variable) predicts weight loss (dependent variable) while adjusting for age, sex, preoperative BMI category (35-40, 40-50, \> 50), and FM, physical activity. This corresponds to 6 adjustment variables altogether, or 3 supplemental variables. According to the rule of Harrel that stipulates at least 10 observations per independent variables, the investigators need at least 70 participants (10\*(1+6)) to perform these adjustments.

Considering a drop-out rate of 30% at 2 years, the investigators will need a sample size of: 70+30% = 91 subjects.

Первичные конечные точки

  • Correlation between Fat-free mass (FFM) and weight loss following RYGB [Срок оценки: 2 years]
  • Evolution of body composition in the two years after bariatric surgery [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Patients ≥ 18 years AND
  • Meeting inclusion criteria for RYGB (www.smob.ch): BMI ≥35 kg/m2, failure of weight-reducing programs over 2 years (for patients with a BMI ≥50 kg/m2, 1 year), understanding of the necessity to change the lifestyle and eating habits post-operatively, signed consent for lifelong post-operative follow-up in a recognized bariatric center AND
  • Scheduled RYGB at the HUG OR previous RYGB at the HUG with a present follow-up in Clinical Nutrition and dietetics at the HUG AND
  • Understanding French

Критерии исключения

  • Inability or refusal to give consent.
  • Planification for another type of bariatric surgery than RYGB
  • Contra-indications to bariatric surgery as stated under www.smob.ch: insufficient nutritional knowledge in nutrition to lose weight, pregnancy, kidney failure (Creatinine ≥ 300 umol/l without dialysis, Crohn's disease, active cancer or remission < 2 years, active psychiatric disease, substance abuse (alcohol, cannabis, opioids), absence of compliance, lack of understanding of the requirements and necessary lifestyle changes reported by physician or dietician.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • Geneva University Hospitals — Geneva

Идентификаторы

NCT: NCT07565051 · 2024-02136

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗