Single Anastomosis Sleeve Jejunal Bypass VS One Anastomosis/Mini Gastric Bypass as Regards GLP-1, PYY, GIP, Insulin Resistance and Type II Diabetes Mellitus Resolution: A Prospective Partially Randomized Patient Preference Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Determine the change in measurable plasma levels of GLP-1 after the assigned operation. GLP-1 levels will be measured using (pmol/L) unit.
研究概览
简要总结
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 mainly, PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
详细描述
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 (as a primary outcome), PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
SASJ Group: composed of 20 patients undergoing SASJ operation. - OAGB Group: composed of 20 patients undergoing OAGB operation.
Convenience sampling was used and the sample size was 40 patients. An informed consent was taken from all patients and all data are confidential, and patients will not be mentioned by name in any published paper. Patients will have the right to refuse joining the research or withdraw at any time without affecting their chance to receive the traditional therapy at any time.
Regarding the Study Procedures, all patients will have preoperative workup including full history taking, general and local examination, laboratory profile including complete blood picture, liver function tests, kidney function tests, clotting profile, fasting and 2-hour postprandial blood glucose, HbA1C, serum insulin level, C-peptide (in non-insulin receiving patients) and Viral markers. Also Serum levels of GLP-1, PYY and GIP, thyroid profile (Free T3, T4 and TSH), pelviabdominal US, and upper GI endoscopy in patients with GERD or when an intra-gastric pathology is suspected. Cardiopulmonary assessment could be done if clinically indicated.
Operative details - One anastomosis gastric bypass includes creation of a proximal gastric pouch and a stapled side to side gastrojejunostomy anastomosis (4.5 cm staple) is made within 200 cm from the ligament of Treitz and below the level of crow's foot. A transverse anastomosis is usually done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age from 18 to 60 years old.
- •Both sexes.
- •Patients with BMI ≥ 35 with Type II diabetes mellitus.
排除标准
- •Patients underwent previous Bariatric surgeries.
- •Patients with severe systemic disease (ASA 4), such as congestive heart failure - unstable angina - recent stroke or myocardial infarction less than 3 months ago.
- •Patients who refuse to participate in the study.
- •Patients with psychiatric illness.
研究组 & 干预措施
SASJ Group
Group of patients undergoing Single Anastomosis Sleeve Jejunal Bypass
干预措施: Single anastomosis sleeve jejunal bypass (Procedure)
OAGB Group
Group of patients undergoing One Anastomosis Gastric Bypass
干预措施: One anastomosis gastric bypass (Procedure)
结局指标
主要结局
Determine the change in measurable plasma levels of GLP-1 after the assigned operation. GLP-1 levels will be measured using (pmol/L) unit.
时间窗: Serum levels of GLP-1 will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative.
Plasma levels of Incretin GLP-1 are measured before and after the assigned operation using ELISA kits.GLP-1 levels will be measured using (pmol/L) unit.
次要结局
- Determine the change in plasma levels GIP after the assigned operation. Serum levels will be measured using (pmol/L) unit.(6-8 weeks post operative)
- Determine the change in plasma levels Peptide-YY (PYY) after the assigned operation. Serum levels will be measured using (pmol/L) unit.(6-8 weeks post operative)
- Total weight loss percentage(6-8 weeks post operative)
- Glycemic control (Fasting)(6-8 weeks post operative)
- Glycemic control (Postprandial)(6-8 weeks post operative)
- Type II DM resolution(6-8 weeks post operative)