Меню
Набор скоро начнётся NCT06865365

Preoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone

Фаза IV С лечением Obesity, Adolescent

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: Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions, Dietologic measures and lifestyle optimization for weight loss.
Кому может быть актуально
Состояния в реестре: Obesity, Adolescent. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective, Randomized, Controlled Trial of Preoperative Use of Saxenda (Liraglutide) Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone

Обзор

The aim of the study is to investigate the effects of preoperative Saxenda (liraglutide). There are two groups, one group receives Saxena in addition to dietary measures when first seeking the operation, one group only diet. The investigator is researching how much additional preoperative weight loss is possible with the drug admitted preoperatively.

Подробное описание

The aim of the study is to investigate the effects of preoperative Saxenda (liraglutide). There are two groups, one group receives Saxena in addition to dietary measures, one group only diet. Each group will have a waiting period of 6 months until the operation will be done. The investigator wants to elaborate how much additional preoperative weight loss is possible with the drug. The greater the preoperative weight loss, the lower the risk of the operation.

After one year, the investigator will also check whether the weight loss has been maintained and whether the preoperative Saxenda continues to lose even more weight after the operation.

All patients looking for bariatric surgery with health insurance via Österreichische Gesundheitsklasse and BMI\>35kg/m2 will be asked to take part in this study.

Patients with previous bariatric surgeries or contraindications against liraglutide will be excluded from this study.

Вмешательства

  • Препарат Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions
    Liraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss
  • Поведенческое Dietologic measures and lifestyle optimization for weight loss
    all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively.

Первичные конечные точки

  • % total weight loss [Срок оценки: body weight and bmi will be assessed immediately when admission to the study is done as reference value and at at time of operation, which is 6 months after admission to the study, as outcome value]
Вторичные конечные точки (3)
  • comorbidities [Срок оценки: The secondary parameters will be assessed immediately at the time when admission to the study is done for reference and the time of the surgery, which is 6 months after admission, as outcome parameter]
  • hba1c [Срок оценки: The secondary parameters will be assessed immediately when admission to the study is done for reference and the time of the surgery, which is 6 months after admission, as outcome parameter]
  • % weight lost after one year [Срок оценки: Body weight will be assessed immediately when admission to the study is done and the time of the surgery (=6 months after admission) and 1 year post op (=18 months after admission)]

Критерии участия

Критерии включения

\- Patients seeking bariatric surgery

  • BMI > 35.0 kg/m2
  • Health insurance via Österreichische Gesundheitskasse
  • Willingness to be assigned to either of the two groups
  • Willingness to adhere to preoperative dietological measures
  • Follow-up anticipation with blood draws and body weight scans using Secca scale
  • Written informed consent

Критерии исключения

  • Patients with previous bariatric surgerys
  • Patients aged below 18 years
  • Patients with BMI < 35 kg/m2
  • Patients with psychiatric disorders
  • Patients not willing to adhere to preoperative dietological measures
  • Patients with contraindications against Saxenda
  • Patients who have health insurance other than Österreichische Gesundheitskasse

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06865365 · 2493/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗