Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of patients in each group reaching the composite end point
研究概览
简要总结
The aim of this study is to investigate the continued usage of standard diabetes medications in the post operative period following bariatric surgery to determine whether this approach may improve long term diabetes control. At present, the standard of treatment in patients with type 2 diabetes is that all medication is stopped in the immediate postoperative period and only re-started if symptoms of diabetes re-emerge. Although a large proportion of patients with diabetes will initially go in to remission, 80% experience relapse within five years. This study is needed to determine whether continuing medications is not only safe but will improve long term outcomes for patients with diabetes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eligible for bariatric surgery according to NICE guidelines (GC 189)
- •Type 2 diabetes mellitus
- •BMI >30kg/m2
排除标准
- •Recent hospitalisation in the past 30 days
- •Recurrent hypoglycaemic episodes
- •Recurrent hypotensive episodes
- •Contraindications to bariatric surgery
- •Previous bariatric surgery
- •Current pregnancy
- •Breastfeeding
研究组 & 干预措施
Control
Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy. Long term diabetes care will be under the supervision of their primary care provider/general practitioner
干预措施: Bariatric surgery (Procedure)
Intervention
Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy and will have ongoing goal directed medical treatment for their T2DM, titrated to specific end points for BP, HbA1c and lipids.
干预措施: Bariatric surgery + goal directed medical therapy (Procedure)
结局指标
主要结局
Proportion of patients in each group reaching the composite end point
时间窗: 5 years
BP\<130/80, HbA1c\<6.5%, LDL\<2.6mmol/L
Proportion of patients reaching end point for glycemic control
时间窗: 1 year
HbA1c\<6.5%
次要结局
- Change in body weight(5 years)
- Change in BMI(5 years)
- Change in waist circumference(5 years)
- Change in lipid control(5 years)
- Change in glycaemic control(5 years)
- Change in blood pressure(5 years)
- Change in liver function(5 years)
- Change in renal function(5 years)
- Change in inflammatory markers(5 years)
- Change in urine albumin: creatinine ratio(5 years)
- Change in quality of life(5 years)