Clinical and Hormonal Study of a New Surgical Treatment of Type 2 Diabetes Mellitus: Duodenal Exclusion Associated With Omentectomy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Improvement or reversal of type 2 diabetes mellitus
研究概览
简要总结
Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a duodenal exclusion in wich the stomach volume is kept intact. We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered.
Further improvement of diabetes could be achieved by intervention in insulin resistance, another factor of diabetes pathophysiology. As that factor is related to visceral fat, we hypothesize that surgical removal of the major omentum, a great component of central adiposity, could beneficial .
This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery plus total omentectomy, by the method of standardized meal stimulus and insulin tolerance test, in human non-obese volunteers with diabetes type 2 and known insulin secretion capacity.
The previously studied volunteers submitted to duodenal exclusion without omentectomy will be the control group.
详细描述
Diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures, followed by those combining malabsorption and gastric restriction. Changes in the hormonal communication between the digestive system (incretins)and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals.
Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a duodenal exclusion: the stomach volume is kept intact, maintaining the caloric ingestion and the weight reduces less than 5%, without the potential nutritional deprivations commonly seen in the bariatric surgery. We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered. An standardized mixed meal tolerance test showed favorable changes in the gastrointestinal hormones that stimulate insulin secretion (incretins): increase of GLP-1 and reduction of GIP.
Further improvement of diabetes could be achieved by intervention in insulin resistance, another factor of diabetes pathophysiology. As that factor is related to visceral fat, we hypothesize that surgical removal of the major omentum, a great component of central adiposity, could beneficial .
In fact, surgical removal of visceral fat in rodents improves insulin sensitivity. A pilot study in human, obese volunteers submitted to gastric adjustable band was promising int this aspect.
This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery plus total omentectomy , by the method of standardized meal stimulus and insulin tolerance test, in human non-obese, volunteers with diabetes type 2 and known insulin secretion capacity.
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
- None
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
- •Age: 18 to 60 years.
- •BMI between 25 and 29,9 kg/m².
- •Weight variance less than 5% in the last 3 months.
- •Previous diagnosis of diabetes type
- •Insulin requirement, alone or along with oral agents
- •Capacity to understand the procedures of the study.
- •To agree voluntarily to participate of the study, signing an informed consent.
排除标准
- •Positive Anti-GAD antibodies
- •Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
- •History of hepatic disease like cirrhosis or chronic active hepatitis.
- •Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
- •Hepatic dysfunction: ALT and/or AST 3x above upper normal limit.
- •Recent history of neoplasia (< 5 years).
- •Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
结局指标
主要结局
Improvement or reversal of type 2 diabetes mellitus
时间窗: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year
次要结局
- Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test(2 months, 6 months and 1 year)
- Changes in seric free fatty acids and lipoproteins(one month, 2 months, 3 months, 6 months and 1 year)
- Improvement of insulin sensitivity as measured by insulin tolerance test.(1 month, 3 months, 6 months and 1 year)
- Changes in seric levels of adiponectin and other adipokines.(2 months, 6 months and 1 year)
- Changes in body weight and fat distribution after intervention(1 month, 2 months, 3 months, 6 months and 1 year)
- Regression of carotid intima-media thickness(1 month, 3 months, 6 months and 1 year)