NCT01857076已完成不适用
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Hospital Sirio-Libanes2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Diabetes remission evaluated by patients glycemic rates
研究概览
简要总结
There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical, gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2 diabetes mellitus and obesity class I. In order to compare the effect of weight loss on glycemic control among medical and surgical groups, and after 2 years of follow up, the results of efficacy, safety and maintenance will be compared between the three groups.
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
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman with Type 2 diabetes mellitus (DM) aged between 25 and 65 years, with time since diagnosis of diabetes less than 10 years.
- •Grade I obesity (BMI between 30-35)
- •Inadequate glycemic control with HbA1c between 7.0 to 9.5% at baseline, in the presence of drug treatment for diabetes in the last year.
- •Reserve pancreatic C-peptide> 1.0 at baseline.
- •Overweight stable defined as BMI> 30 in the last two years.
排除标准
- •History ketoacidosis, diabetes mellitus type 1, diabetes followed by pancreatitis.
- •Repetition of measurements (ie, 2 or more within 1 week) fasting plasma glucose(FPG) > 240 mg / dL during the pre-treatment.
- •History of Severe Proliferative Diabetic Retinopathy.
- •Autonomic neuropathy.
- •Loss or gain significant weight within the last 12 weeks (range, 5% body weight)
- •Renal insufficiency
- •History of renal disease treated with immunosuppressive therapy, history of dialysis or kidney transplantation.
- •Presence of other renal diseases (eg nephrotic syndrome, glomerulonephritis)
- •Acute myocardial infarction, unstable angina (NYHA class III-IV), revascularization or stroke within the previous 3 months of the initial visit.
- •Uncontrolled hypertension defined as diastolic blood pressure> 100mm/Hg and diastolic blood pressure> 160mm/Hg at the initial visit.
- •History of Hepatitis B or Hepatitis C.
- •Criteria for Hepatic insufficiency defined as Child B and C liver disease clinically active and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above 3 times the upper limit of normal.
- •History of prior bariatric surgery.
- •Inflammatory Bowel Disease.
- •History neoplasm within the last 5 years (except for squamous cell carcinoma and basal skin and cervical carcinoma in situ)
- •Clinically important hematologic disorder (symptomatic anemia, bone marrow proliferative disorders, thrombocytopenia, ..)
- •History antibody positive human immunodeficiency virus (HIV)
- •Surgery with general anesthesia within 12 weeks prior to the initial visit or incomplete recovery from prior surgery.
- •History of drug or alcohol abuse within 3 years before the initial visit.
- •Pregnancy or breastfeeding or planning pregnancy in the next two years.
结局指标
主要结局
Diabetes remission evaluated by patients glycemic rates
时间窗: In 2 years
Comparison of diabetes remission between the two surgical modalities.
Glycemic blood rates
时间窗: In 2 years
Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.
次要结局
- Quality of life evaluation(In 2 years)
- Number of Late Adverse Events(In 2 years)
- Weight loss(In 2 years.)
- Decrease in blood lipid(In 2 years)
- Number of Early Adverse Events(In 2 years)
- Number os Nutricional Complications(In 2 years)
研究者
Cláudia Cozer
Md
Hospital Sirio-Libanes
研究点 (2)
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