METABOLIC SURGERY FOR PATIENTS WITH TYPE 2 DM AND GRADE I OBESITY (BMI 30-35 kg/m2) WITH BAD METABOLIC CONTROL (HbA1c > 7,5%) PROTOCOL
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participans with normal glycosylated hemoglobin levels
研究概览
简要总结
The aim of the study is to compare the efficacy of laparoscopic gastric bypass versus vertical gastrectomy for the resolution of DM in patients with BMI 30-35.
详细描述
Hyphotesis Laparoscopic gastric bypass is the elective technique in the face of sleeve gastrectomy to improve or heal type 2 diabetes mellitus in patientes with BMI 30-35 kg/m2.
MAIN AIM:
To compare cure rate through the improvement in glycated hemoglobin and fasting glycaemia after laparoscopic gastric bypass face to sleeve gastrectomy.
SECONDARY AIMS:
To quantify both insulin and oral hypoglycemic agents dose decrease. To measure weight loss and its maintenance during the follow-up in both techniques.
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
- Double (Participant, Care Provider)
盲法说明
The study will be blinded for patients, who will not know the surgery technique they will go on. Dieticians and Endocrinologists who will follow the patients up after the surgery neither will not know it, so differences in dietary recommendations will not appear with this masking.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sex patients aged between 18 and 65 years old
- •Class I obesity (BMI 30-35 kg/m2) with bad metabolic control (DM-2 with HbA1c > 7,5%) and non-insulin anti-diabetic treatment failure (it is necessary >10 years of known diabetes evolution time, C-peptide≥ 1 ng/ml, no insulin treatment, at least two oral hypoglycemic agents treatment);
- •Patients who accomplish the follow-up protocol designed by both Surgery and Endocrinology departments
- •Informed consent signed
排除标准
- •Patients who do not accomplish the previosly described inclusion criteria; Patient's refusal to take part in the study; Patients with symptomatology of gastroesophageal reflux disease or with upper gastrointestinal series compatible with this desease.
- •Previous bariatric surgery
研究组 & 干预措施
Gastric bypass
Twenty patients will be randomly assigned to perform a laparoscopic gastric bypass.
干预措施: metabolic surgery (Procedure)
Slevee gastrectomy
Twenty patients will be randomly assigned to perform a sleeve gastrectomy
干预措施: metabolic surgery (Procedure)
结局指标
主要结局
Number of participans with normal glycosylated hemoglobin levels
时间窗: 1 year after surgery
Healing will be defined when HbA1c and fasting glycaemia levels are inside normal limits (Hb1Ac \< 6%, FBG\<100mg/dl) without needing oral hypoglycemic agents.
次要结局
- Number of participants with partial remission or improvement of diabetes(1 year after surgery)
- Comparison of weight loss between the two techniques; bypass and sleeve.(2 years after surgery)
- Evaluation of postoperative complications in patients undergoing bypass and slevee with Clavien-Dindo classification.(1 month after surgery)
- Comparison postoperative pain in sleeve and bypass with analogue assessment scale of postoperative pain.(3 days postoperative)
研究者
Nuria Peris Tomás
Principal Investigator
Hospital Universitario Doctor Peset