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临床试验/NCT02390973
NCT02390973招募中不适用

Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)

Laval University2 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
408
试验地点
2
主要终点
Type 2 diabetes remission rate

研究概览

简要总结

Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The mechanisms underlying type 2 diabetes remission and others metabolic improvements after Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a longitudinal study with the overall objective of measuring the long-term impact of these three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric procedures generate hitherto unrecognized effects on many disease-related outcomes, which greatly contributes to their beneficial impact in diabetic patients. The investigators propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the metabolic recovery and quality of life in groups of diabetic patients treated with insulin, hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on renal and cardiovascular functions in subgroup of patients with these conditions; 3) to compare metabolic impact of surgeries to those of best medical care for diabetes in a non-surgical control group. For most severely obese patients, lifestyle interventions, perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity surgeries calls for a better understanding of the underlying mechanisms. This is especially true and urgent when considering that knowledge on the relative impact of each procedure (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of the procedures will allow stronger scientific rationale for selecting the right surgery for the right patient and improve care for the severely obese individual.

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

入选标准

  • type 2 diabetes
  • HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
  • able to consent

排除标准

  • pregnancy
  • past esophageal, gastric or bariatric surgery
  • irritable bowel, unexplained intermittent vomiting, severe abdominal pain, chronic diarrhea or constipation
  • history of gastric or duodenal ulcers
  • pre-operatory hypoalbuminemy
  • history of renal, hepatic, cardiac or pulmonary severe disease
  • taken of corticosteroid in the last month
  • evidence of psycological problem that may affect the capacity to understand the project and to comply with the medical recommandations
  • history of drug use or alcool abuse in the last 12 months
  • history of gastro-intestinal inflammatory diseases

结局指标

主要结局

Type 2 diabetes remission rate

时间窗: from baseline up to 60 months

percent of patient achieving type 2 diabetes remission in each groups

次要结局

  • GERD remission rate(from baseline up to 60 months)
  • Sleep apnea remission rate(from baseline up to 60 months)
  • weight loss(from baseline up to 60 months)
  • Dislipidemia remission(from baseline up to 60 months)
  • Change in microalbuminuria(from baseline up to 60 months)
  • Change in retinopathy(from baseline up to 60 months)
  • Hypertension remission rate(from baseline up yo 60 months)
  • Regression of liver disease(from baseline up to 60 months)
  • Quality of life(from baseline up to 60 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurent Biertho

Principal Investigator

Laval University

研究点 (2)

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