Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes

Официальное название

CHANGE Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes

Обзор

Surgery is one of the management options for type 2 diabetes in patients with moderate obesity. This is a recent option because it has been part of the recommendations since October 2022. The possible surgical techniques are the same as those for bariatric surgery: * Sleeve, * Bypass, * Gastric band, but the main goal is not weight loss, it is remission of type 2 diabetes. It is called metabolic surgery. The ring technique (gastroplasty) is practiced less and less in France because it is less effective in weight loss and is responsible for major discomfort. Currently, metabolic surgery is one of the recommendations but no study has compared the effectiveness of the techniques with each other. One or other of the techniques can be chosen according to the preferences of the surgeon, the patient, the center, etc. but this choice is not made objectively, in the absence of comparative data. This study would like to follow up on patients for whom metabolic surgery has been proposed by the doctor,. If the surgery is accepted, this study would like to improve knowledge of the effectiveness of the different techniques, and thus demonstrate which metabolic surgery technique is preferred in terms of effectiveness and safety.

Вмешательства

• Процедура metabolic surgery with SLEEVE technique
  metabolic surgery with SLEEVE technique
• Процедура metabolic surgery with BY-PASS technique
  metabolic surgery with BY-PASS technique

Первичные конечные точки

• T2DM remission rate [Срок оценки: 1 year after surgery]

Критерии участия

Критерии включения

• adult patient and ≤ 65 years old
• T2D patient, with individualized glycemic objectives not achieved, despite medical care, in particular diabetological and nutritional, also including adapted physical activity, well conducted according to current good practice recommendations, for at least twelve months
• BMI between 30 and 34.9 kg/m²
• patient well informed beforehand about metabolic surgery and the study
• multidisciplinary evaluation (including a diabetologist) and decision on medical treatment by CM (date prior to inclusion)
• medical assessment of an acceptable surgical risk
• patient affiliated to or beneficiary of a social security system
• patient having freely signed the written informed consent

Критерии исключения

• severe cognitive or mental disorders
• severe and unstabilized eating behavior disorders
• dependence on alcohol and licit and illicit psychoactive substances
• illnesses endangering life in the short and medium term
• contraindications to general anesthesia
• absence of identified prior medical care and foreseeable inability of the patient to participate in lifelong medical monitoring
• history of bariatric surgery
• pregnant or breastfeeding woman, or having a very long-term pregnancy plan short term (\< 2 years)
• adult patient under guardianship or curatorship
• patient deprived of liberty or under judicial decision

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

Франция · 1 центр

• Medipole Lyon Villeurbanne — Villeurbanne

Идентификаторы

NCT: NCT06600555 · CHANGE metabolic surgery

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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