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临床试验/NCT02488733
NCT02488733进行中(未招募)不适用

Laparoscopic Sleeve Gastrectomy Versus Conventional Medical Therapy in Patients With Newly Diagnosed Type 2 Diabetes and Body Mass Index 30-42 Kg/m2: a Randomized Clinical Trial

Azienda Ospedaliera Santa Maria, Terni, Italy2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Rate of patients achieving diabetes resolution

研究概览

简要总结

Bariatric surgery is efficient in both inducing adequate weight loss and the control of glycemia in obese patients affected by Type 2 Diabetes Mellitus (T2DM).

Despite growing evidence suggesting that early performance of bariatric surgery on obese patients with T2DM offers the best opportunity to reach and maintain a remission of diabetes, no randomized clinical trials (RCT) have evaluated its efficiency in patients with new T2DM diagnosis.

The aim of this RCT is to compare bariatric surgery, and in particular Laparoscopic Sleeve Gastrectomy (LSG), with conventional medical therapy (CMT) in patients with new T2DM diagnosis that are obese (Body Mass Index, BMI of between 30 and 42 Kg/m2), to be recruited at two Italian diabetology centres (Terni and Rome).

The main objective of the present RCT is to investigate the efficacy of LSG as compared with CMT in inducing and maintaining both a resolution of T2DM (defined as HbA1c levels ≤6.0%, without active pharmacologic therapy or ongoing procedures) and the remission of T2DM through the evaluation of the criteria provided by the American Diabetes Association (ADA) at maximum follow-up of 6 years. The effects of the two treatments in terms of weight loss and the quality of life of the patient will also be taken into consideration.

Any positive results of this study will include preventing microvascular and macrovascular complications connected with diabetes, without the necessity to take medication, and at the same time the loss of excess body weight and improved quality of life (QOL).

详细描述

Recent evidence suggests that, in obese patients with type 2 diabetes mellitus of long duration, and / or poorly controlled with conventional therapy, bariatric surgery promises diabetes remission rates significantly higher than those attainable with traditional treatment, irrespective of initial BMI and the loss of body weight of the patients.

This has ensured the growing conviction in the international scientific community that bariatric surgery should not be considered as an alternative to conventional obesity and diabetes therapies only after the failure of traditional treatments, but should be performed with the intent to prevent complications associated with these diseases, and therefore at their onset [23]. Furthermore, the use of BMI as the main parameter to guide the indication of bariatric surgery is increasingly being called into question with regard to the presence of comorbidities such as diabetes, as it is the distribution of obesity, together with the presence of comorbidities such as diabetes, rather than the degree of obesity that predicts the onset of related complications.

Bariatric surgery is currently regarded as a "last resort" for both the treatment of obesity and its associated comorbidities, such as diabetes, particularly in patients with a BMI ≤ 35. Despite this, it is now apparent that initial BMI and body weight loss resulting from bariatric surgery have no connection with the metabolic effects of the procedure, such as on the treatment of diabetes. In fact, according to the current national and international guidelines (which are based on a consensus dated 1991[6]), bariatric surgery may be considered in diabetic patients, with a BMI between 30 and 39.9 Kg/m2, only after the recorded failure of conventional medical therapies for obesity and diabetes.

This wait-and-see policy is due to the fact that bariatric surgery is a surgical procedure that is associated, depending on the procedure, with a certain rate of short and long term potential adverse events, and while in the short-medium term it has been shown to achieve significantly higher rates of remission from diabetes, when compared to medical therapy, there remain uncertainties about the durability of remission of diabetes and weight control after long follow-up periods. Essentially, therefore, the risk-benefit ratio has not allowed for the use of bariatric surgery as a first-line therapy for the treatment of type 2 diabetes in obese patients, and in particular in class 1 and 2 obesity. It can be hypothesized, however, that the performance of LSG at diagnosis of diabetes in obese patients can dramatically improve both the resolution/remission rate and the duration of resolution/remission from diabetes, and thus improve the protection against the development of vascular complications.

In fact, growing evidence suggests that the period of time between the diagnosis of diabetes and bariatric surgery is a determining factor in the achievement and duration of diabetes remission. It has also been observed that bariatric surgery is more effective than medical therapy in preventing diabetes in obese patients.

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
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No contraindication for laparoscopic surgery or general anaesthesia.
  • Age ≥20 and ≤65 years.
  • BMI of between 30 and 42 kg/m
  • Documented new diagnosis of Type 2 Diabetes Mellitus obtained according to the following American Diabetes Association parameters: fasting blood glucose ≥ 126 mg/dl (7.0 mmol/l) and/or HbA1c ≥ 6.5% and no more than 8 months from enrollment in the study.

排除标准

  • Previous bariatric surgery or major abdominal surgery.
  • Patients with T2DM diagnosis treated with insulin.
  • Evidence of complications connected to diabetes at any stage (diabetic retinopathy, diabetic nephropathy/microalbuminuria, cardiovascular disease or neuropathy).
  • Cardiovascular diseases such as ischemia / coronary artery disease, arrhythmia, peripheral vascular diseases, congestive heart failure, history of heart attacks.
  • Kidney diseases including nephro-vascular hypertension, stenosis of the renal artery or chronic renal insufficiency.
  • Diagnosis of psychiatric illness (including dementia, severe depression, history of suicide attempts) or abuse of alcohol or drugs in the previous 5 years.

研究组 & 干预措施

Laparoscopic Sleeve Gastrectomy (LSG)

Experimental

In addition to conventional medical therapy, patients assigned to surgical treatment will undergo LSG, to be performed in accordance with current international guidelines.

干预措施: LSG (Procedure)

Laparoscopic Sleeve Gastrectomy (LSG)

Experimental

In addition to conventional medical therapy, patients assigned to surgical treatment will undergo LSG, to be performed in accordance with current international guidelines.

干预措施: CMT (Drug)

Conventional medical therapy (CMT)

Other

CMT consists in the use of the best treatment strategies, involving pharmacological and dietary therapies, lifestyle and physical activity, with the aim of both glycemic control and weight loss.

干预措施: CMT (Drug)

结局指标

主要结局

Rate of patients achieving diabetes resolution

时间窗: Assessed up to 1 year after randomization

HbA1c levels ≤6.0%, without active pharmacologic therapy or ongoing procedures

次要结局

  • Rate of patients achieving diabetes resolution(assessed at 2, 3, 4, 5 and 6 years after randomization)
  • Rate of patients achieving diabetes complete remission (American Diabetes Association criteria)(assessed at 2, 3, 4, 5, and 6 years after randomization)
  • Rate of patients achieving HbA1c levels ≤6.5%,(assessed up at 1, 2, 3, 4, 5,and 6 years after randomization)
  • Rate of patients achieving prolonged remission (American Diabetes Association criteria)(Assessed up at 6 years after randomization)
  • Time to achievement (in days) of complete remission(Assessed up at 2 years after randomization)
  • Time to achievement (in days) of prolonged remission(Assessed up at 6 years after randomization)
  • Total duration of the period with diabetes resolution(Assessed at 3 and 6 years)
  • Total duration of the period in complete remission(Assessed at 3 and 6 years)
  • Total duration of the time period with HbA1c ≤ 6.0% irrespective of any active pharmacologic therapy or ongoing procedures(Assessed at 3 and 6 years)
  • Total duration of the period with HbA1c levels ≤6.5%, without active pharmacologic therapy or ongoing procedures(Assessed at 3 and 6 years)
  • Total duration of the period with HbA1c levels ≤6.5% irrespective of any active pharmacologic therapy or ongoing procedures(Assessed at 3 and 6 years)
  • Average value and changes from baseline, during the follow-up period, until the predefined time end-points of anthropometric, blood, urinary and QoL parameters.(Assessed up at 6 years after randomization)
  • Rate of patients with effective weight loss (defined as % Excess Weight Loss > 50%)(Assessed at 2 ,4, 6 years after randomization)
  • Rate of patients with hypertension and / or requiring antihypertensive therapy(Assessed at 2,4, 6 years after randomization)
  • Rate of patients with dyslipidemia and / or that require drug therapy for dyslipidemia(Assessed at 2,4 6 years after randomization)
  • Complications related to diabetes, or its pharmacological treatment, as well as those resulting from bariatric surgery.(Assessed at 2,4 6 years after randomization)
  • Renal (onset of nephropathy or microalbuminuria), cardiovascular (defined as the occurrence of myocardial infarction, congestive heart failure or stroke), and ocular damage (development of diabetic retinopathy), and diabetes-related peripheral neuropathy(Assessed at 2,4, 6 years after randomization)
  • Rate of patients achieving HbA1c levels ≤6.5%,(assessed at 1, 2, 3, 4, 5,and 6 years after randomization)

研究者

发起方
Azienda Ospedaliera Santa Maria, Terni, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Trastulli

Azienda Ospedaliera Santa Maria, Terni, Italy

Azienda Ospedaliera Santa Maria, Terni, Italy

研究点 (2)

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