Modified Duodenal Switch Procedure "Duodenal-Jejunal Bypass" (Diabetes Surgery) As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Patients- a Pilot Project to Validate a Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Measure: Resolution of Type 2 Diabetes Mellitus
研究概览
简要总结
Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose and HbA1c in the abscence of medication support is possible with a surgical procedure named the "Duodenal-Jejunal Bypass (DJB)" a modification of an established duodenal switch procedure and is performed utilizing the laparoscopic approach.
详细描述
Hypothesis
The duodenum plays a major role in glucose homeostasis through mechanisms largely unknown at this time. Evidence of this hypothesis comes from accumulated data in bariatric surgery patients who underwent Roux-en-y Gastric Bypass or Biliopancreatic Diversion (BPD) with or without a Duodenal Switch. Current evidence strongly supports this hypothesis with a long term (over 10 years) Type 2 Diabetes Mellitus(T2DM) resolution rate of 84-86% following the gastric bypass and over 95% for the duodenal switch.
The clinical resolution of T2DM is defined as independence of all anti-diabetic medications and maintaining a HbA1c less than 6.0. Recent rodent experiments by Francesco Rubino and subsequent human case reports by Cohen et al. supports the validity of this hypothesis. The modified procedure involved a roux-en-y bypass of the duodenum and 30-50cm of proximal jejunum, unaltering the stomach and pylorus resulted in resolution of T2DM with no weight loss in all subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Established diagnosis of Type 2 diabetes mellitus
- •Body Mass Index(BMI) less than 35
- •Insulin usage duration less than 10 years
- •Negative anti-GAD
- •Fasting C-peptide level over 1.0 mcg/ml
- •Ability and willingness to follow up for a period of 1 year
- •Willingness to consent for utilizing personal results without individual identifier information to be published in medical studies and other media as determined by the study investigators
- •Ability to understand and describe the risks, benefits and mechanism of action of the procedure
排除标准
- •Current pregnancy or positive pregnancy test
- •Liver Cirrhosis
- •Coagulopathy
- •Type 1 Diabetes Mellitus
- •Previous abdominal surgery preventing laparoscopy
- •Previous vagotomy
- •Previous gastric or small intestine surgery
- •Inability to comply with study requirements
- •Currently active medical malpractice lawsuit/s
- •Diseases of the exocrine pancreas: pancreatitis trauma, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis
- •Endocrinopathies: acromegaly, glucagonoma, Cushing's Syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldorestanoma
- •Chemical Induced Diabetes: vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormones, diazoxide, beta-adrenergic agonists, thiazides, phenytoin, alfa-interferon
- •Genetic Syndromes with Diabetes: Down's, Klinefelter's, Turner's, Wolfram, Lawrence-Moon- Beidel, Prader-Willi, Friederich's ataxia, Huntington's Chorea, Myotonic Dystrophy, Porphyria,
- •If a candidate is deemed to be not an appropriate candidate based on investigators recommendation.
结局指标
主要结局
Measure: Resolution of Type 2 Diabetes Mellitus
时间窗: One year
次要结局
- Measure: Safety and efficacy of duodenal-jejunal bypass(One year)