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Идёт набор NCT05211375

Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial

Фаза III С лечением Diabetes Mellitus, Type 2 Bariatric Surgery Surgical Procedures, Operative Asians

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: Duodenojejunal bypass, Sleeve gastrectomy.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 2, Bariatric Surgery, Surgical Procedures, Operative, Asians. 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
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

In this study, the effects of SG with DJB and SG alone for the treatment of type 2 diabetes mellitus (T2DM) will be compared in patients other than the two groups at both extremes who are expected to show excellent effects of metabolic surgery with SG alone (mild T2DM) and who need SG with DJB (severe T2DM). This study is to target patients with poor blood sugar control despite current medical treatment, although the beta-cell function of the pancreas is preserved. Therefore, this study is aimed at patients who have been using insulin for less than 10 years with T2DM, or taking diabetic medications with HbA1c ≥ 7.0% for less than 10 years with T2DM. The investigators hypothesize that the treatment effects of SG with DJB for T2DM will be superior to that of SG in this group

Подробное описание

Most Asian patients undergoing metabolic surgery for the treatment of T2DM have BMI as low as 30-35 kg/m2. If SG is performed for the treatment of T2DM in these patients, weight may decrease after the surgery; however, T2DM may recur after 6 months to 1 year. Therefore, it is difficult to find clinical studies on SG for metabolic surgery in Asians, and gastric bypass may be more appropriate as metabolic surgery. However, gastroscopy for the remnant stomach after gastric bypass is practically impossible. Therefore, gastric bypass may be a fatal drawback for East Asian patients with a high incidence of gastric cancer. In recent years, modified duodenal switch (SG with duodenojejunal bypass \[DJB\], which is defined as the procedure that makes jejunal bypass shorter than the traditional duodenal switch) is often performed as metabolic surgery, and studies on this surgical technique are being actively conducted in Japan.

SG with DJB has both effects of stomach restriction and foregut bypass. However, SG with DJB is more disadvantageous compared to SG alone in nutrient absorption after surgery. This is a natural result of bypassing the duodenum and proximal jejunum. Therefore, SG with DJB should not be performed when it is unnecessary, and it should be performed in patients who are expected to show significant improvement in T2DM. However, there is no existing guideline on which patients can receive SG with DJB or SG alone, and there are also no clinical studies on these aspects.

Вмешательства

  • Процедура Duodenojejunal bypass
    Sleeve gastrectomy will be performed in the same manner as in the SG group. DJB will be performed by transection of the duodenum and bypassing 250 cm of the proximal jejunum. The handsewn suture will be used for duodenojejunal anastomosis, and the size of anastomosis will be 1.5 - 2 cm. Single anastomosis will be performed rather than Roux-en-Y fashion.
  • Процедура Sleeve gastrectomy
    Sleeve gastrectomy will be performed using 36-38 Fr bougie. The initial stapling start point will be between 4-6 cm from the pylorus, and the last stapling will be performed at least 1 cm away from His angle. The height of the automatic stapler will be selected based on the researcher's discretion.

Первичные конечные точки

  • Complete remission rate of type 2 diabetes [Срок оценки: 5 years after surgery]
Вторичные конечные точки (12)
  • Complete remission rate of type 2 diabetes [Срок оценки: 1, 3, 10 years after surgery]
  • Partial remission rate of type 2 diabetes [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Improvement rate of type 2 diabetes [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Hypertension remission rate [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Hypertension improvement rate [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Hyperlipidemia remission rate [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Hyperlipidemia improvement rate [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Prevalence of GERD [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Trace element deficiency rate (iron, vitamin B12, folate, vitamin B1, vitamin D, copper [Cu], and zinc [Zn]) [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Changes in body weight [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Changes in body composition [Срок оценки: 1, 3, 5, 10 years after surgery]
  • Changes in Quality of life [Срок оценки: 1, 3, 5, 10 years after surgery]

Критерии участия

Критерии включения

  • Age over 18 years
  • BMI equal to or greater than 27.5 kg/m2
  • T2DM duration ≤ 10 years
  • Using insulin, or HbA1c ≥ 7.0% while taking diabetes medication
  • C-peptide level higher than 1.0 ng/mL
  • Presence of type 2 diabetes fulfilling the following criteria
  • Consent to not become pregnant for at least 1 year after surgery
  • Willingness to provide voluntary informed consent

Критерии исключения

  • Presence of uncontrolled severe gastroesophageal reflux (LA classification C or more in esophagogastroduodenoscopy)
  • History of previous metabolic surgery for T2DM
  • History of gastrointestinal surgery, such as gastrectomy or anti-reflux surgery, which may affect the result of metabolic surgery
  • Therapy regimen of more than 3 psychiatric drugs owing to poorly controlled psychiatric disorders
  • Suicidal attempts within the last 12 months
  • Treatment for alcohol and drug abuse within the last 12 months
  • Vulnerability factors (lacking mental capacity, pregnancy or planning of pregnancy, lactation)
  • Unsuitability as per the discretion of the researcher

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Seoul National University Bundang Hospital — Seongnam-si

Публикации

  • Hofso D, Fatima F, Borgeraas H, Birkeland KI, Gulseth HL, Hertel JK, Johnson LK, Lindberg M, Nordstrand N, Cvancarova Smastuen M, Stefanovski D, Svanevik M, Gretland Valderhaug T, Sandbu R, Hjelmesaeth J. Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Dec;7(12):912-924 PMID 31678062
  • Aminian A, Brethauer SA, Andalib A, Nowacki AS, Jimenez A, Corcelles R, Hanipah ZN, Punchai S, Bhatt DL, Kashyap SR, Burguera B, Lacy AM, Vidal J, Schauer PR. Individualized Metabolic Surgery Score: Procedure Selection Based on Diabetes Severity. Ann Surg. 2017 Oct;266(4):650-657. doi: 10.1097/SLA.0000000000002407. PMID 28742680
  • Brethauer SA, Kim J, el Chaar M, Papasavas P, Eisenberg D, Rogers A, Ballem N, Kligman M, Kothari S; ASMBS Clinical Issues Committee. Standardized outcomes reporting in metabolic and bariatric surgery. Surg Obes Relat Dis. 2015 May-Jun;11(3):489-506. doi: 10.1016/j.soard.2015.02.003. No abstract available. PMID 26093765

Идентификаторы

NCT: NCT05211375 · MEDUSA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗