Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Complete remission rate of type 2 diabetes
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Complete remission rate of type 2 diabetes
时间窗: 5 years after surgery
HbA1c \<6% (or fasting blood glucose \[FBG\] \<100 mg/dL) without using any diabetes medication
次要结局
- Partial remission rate of type 2 diabetes(1, 3, 5, 10 years after surgery)
- Early complication rate(Early: within 30 days after surgery)
- Complete remission rate of type 2 diabetes(1, 3, 10 years after surgery)
- Hyperlipidemia remission rate(1, 3, 5, 10 years after surgery)
- Trace element deficiency rate (iron, vitamin B12, folate, vitamin B1, vitamin D, copper [Cu], and zinc [Zn])(1, 3, 5, 10 years after surgery)
- Hypertension remission rate(1, 3, 5, 10 years after surgery)
- Late complication rate(Late: later than 30 days after surgery)
- Hyperlipidemia improvement rate(1, 3, 5, 10 years after surgery)
- Changes in body weight(1, 3, 5, 10 years after surgery)
- Changes in body composition(1, 3, 5, 10 years after surgery)
- Changes in Quality of life(1, 3, 5, 10 years after surgery)
- Improvement rate of type 2 diabetes(1, 3, 5, 10 years after surgery)
- Hypertension improvement rate(1, 3, 5, 10 years after surgery)
- Prevalence of GERD(1, 3, 5, 10 years after surgery)
研究者
Young Suk Park, MD
Principle Investigator
Seoul National University Bundang Hospital