Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6%
研究概览
简要总结
Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients with obesity. Many patients stop or reduce their medication after surgery and this can happen fairly quickly. The investigators do not know whether strict control of blood glucose/sugar after the operation makes any difference in the long term. Additionally many patients prefer their blood sugars to be a "bit high" because they are afraid of hypos.A number of studies have described patients whose eye, nerve and kidney disease has deteriorated when high sugars are controlled very quickly. The investigators want to ensure that surgery provides maximum benefit and remains safe in patients with diabetes. This study will help us decide if the investigators should be strict with blood glucose after obesity surgery operations or not and whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.
详细描述
Subjects would be randomised into intensive glycaemic control and conventional glycaemic control after obesity surgery. Data on complications of diabetes such as eye, nerve and kidney will be collected before obesity surgery and 1 year after surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery
排除标准
- •Patients with Type 2 Diabetes Mellitus who do not require insulin immediately after obesity surgery
研究组 & 干预措施
Intensive glycaemic control
Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
干预措施: Insulin (Drug)
Conservative glycaemic control
Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
干预措施: Insulin (Drug)
结局指标
主要结局
Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6%
时间窗: 1 year after surgery
Patients will be tested off all anti-diabetes medications if safe to do so to assess the percentage of patients with Type 2 Diabetes Mellitus who achieve fasting blood glucose of less than 5.6 mmol/l and/or HbA1c of less than 6%
次要结局
- Percentage of Type 2 Diabetes Mellitus Patients With a Reduction in the Doses/Number of Diabetes Medications Used Preoperatively(1 year after surgery)
- Number of Participants With Microvascular Events(1 year after surgery)
研究者
Carel Le Roux
Consultant metabolic medicine
Imperial College London