New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I
New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2
Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.
This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
研究概览
详细说明
Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.
Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity.
This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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SP
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Campinas、SP、巴西
- LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Obesity grade I (BMI 30-34,9)
- Weight variance less than 5% in the last 3 months.
- Previous diagnosis of diabetes type 2.
- 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.
Exclusion Criteria:
- 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: aspartate aminotransferase or alanine aminotransferase 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
Roux-en-Y bypass gastroplasty
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Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch.
A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm.
A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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2型糖尿病的改善或逆转
大体时间：7天、14天、21天、1个月、2个月、3个月、6个月和一年。
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7天、14天、21天、1个月、2个月、3个月、6个月和一年。
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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干预后体重和脂肪分布的变化
大体时间：1个月、2个月、3个月、6个月和1年
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1个月、2个月、3个月、6个月和1年
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颈动脉内膜中层厚度的回归
大体时间：1个月、3个月、6个月和1年
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1个月、3个月、6个月和1年
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Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test
大体时间：6 months and 1 year
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6 months and 1 year
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Improvement of insulin sensitivity as measured by insulin tolerance test
大体时间：1 month, 3 months, 6 months and 1 year
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1 month, 3 months, 6 months and 1 year
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Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines
大体时间：one month, 2 months, 3 months, 6 months and 1 year
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one month, 2 months, 3 months, 6 months and 1 year
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Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography
大体时间：1 year and 2 years
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1 year and 2 years
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Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography
大体时间：1 year and 2 years
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1 year and 2 years
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Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection
大体时间：6 months, 1 year and 2 years
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6 months, 1 year and 2 years
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合作者和调查者
调查人员
- 首席研究员：José Carlos Pareja, MD, PhD、University of Campinas (UNICAMP)
- 首席研究员：Bruno Geloneze, MD, PhD、University of Campinas (UNICAMP)
出版物和有用的链接
一般刊物
- Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.
- Pories WJ, MacDonald KG Jr, Flickinger EG, Dohm GL, Sinha MK, Barakat HA, May HJ, Khazanie P, Swanson MS, Morgan E, et al. Is type II diabetes mellitus (NIDDM) a surgical disease? Ann Surg. 1992 Jun;215(6):633-42; discussion 643. doi: 10.1097/00000658-199206000-00010.
- Geloneze B, Tambascia MA, Pilla VF, Geloneze SR, Repetto EM, Pareja JC. Ghrelin: a gut-brain hormone: effect of gastric bypass surgery. Obes Surg. 2003 Feb;13(1):17-22. doi: 10.1381/096089203321136539.
- Geloneze B, Tambascia MA, Pareja JC, Repetto EM, Magna LA. The insulin tolerance test in morbidly obese patients undergoing bariatric surgery. Obes Res. 2001 Dec;9(12):763-9. doi: 10.1038/oby.2001.105.
- Pories WJ. Diabetes: the evolution of a new paradigm. Ann Surg. 2004 Jan;239(1):12-3. doi: 10.1097/01.sla.0000102990.47956.98.
- Fellici AC, Lambert G, Lima MM, Pareja JC, Rodovalho S, Chaim EA, Geloneze B. Surgical treatment of type 2 diabetes in subjects with mild obesity: mechanisms underlying metabolic improvements. Obes Surg. 2015 Jan;25(1):36-44. doi: 10.1007/s11695-014-1377-9.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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