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临床试验/NCT01213563
NCT01213563终止不适用

Protocol Driven Management of Type 2 Diabetes After Gastric Bypass Surgery

Imperial College London1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
50
试验地点
1
主要终点
efficacy and safety of an intensive glycaemic protocol after bariatric surgery

研究概览

简要总结

Gastric bypass surgery has been proposed as an effective treatment strategy for type 2 diabetes mellitus (T2DM), but thus far algorithms for the management of T2DM immediately after surgery have not been established. The investigators designed an algorithm to achieve good glycaemic control in patients with insulin-requiring T2DM upon discharge after gastric bypass surgery, and evaluated this algorithm for feasibility, efficacy, and safety.

详细描述

This is a prospective randomised controlled intervention study on obese human subjects with Type 2 Diabetes Mellitus undergoing obesity surgery (n=80). Patients will be recruited from those already due to undergo bariatric surgery within the context of the obesity clinic (Imperial College London). Patients will be randomised to either of two treatment protocols.

Protocol A-Conservative Management: On admission to hospital all pre-operative oral antidiabetic agents and insulin are stopped and glucose monitoring is carried out every four hours at the same time as routine observations. Actrapid insulin is administered with glucose as per standard sliding scale (Appendix A). Just prior to discharge, total insulin administered over the previous 24 hour post-operative period is calculated. Based on the results of ward based glucose monitoring, post-operative patients can be divided in two broad categories.

The first group includes patients who are able to maintain euglycaemia without exogenous insulin administration. These patients are discharged home on their preoperative Metformin dose and are advised to continue monitoring their fasting glucose levels at home. If fasting glucose levels of less than 4 or more than 10mmol/l are recorded at home, the patients are encouraged to contact the obesity clinic physicians for advice.

The second group includes patients experiencing hyperglycemic episodes in the immediate post-operative period. These patients are discharged home on their preoperative Metformin dose and once daily insulin Glargine as decided by the discharging doctor (or based on half their last 24 hour requirements) and are advised to continue monitoring their fasting glucose levels at home. If fasting glucose levels of less than 4 or more than 10mmol/l are recorded at home, the patients are encouraged to contact the obesity clinic physicians for advice.

Protocol B-Intensive management: On admission to hospital all pre-operative oral antidiabetic agents and insulin are stopped and glucose monitoring is carried out every four hours at the same time as routine observations. Actrapid insulin is administered as per standard sliding scales (appendix A). Just prior to discharge, total insulin administered over the previous 24 hour post-operative period is calculated. Based on the results of ward based glucose monitoring patients are discharged home on metformin 1000mg BID and/or the equivalent amount of Glargine insulin requirement in previous 24 hours prior to discharge. These patients are also advised to continue glucose monitoring at home and will be contacted every day and their medication adjusted to maintain a fasting glucose between 5 and 7mmol/l. When this is consistently achieved the investigators will stop calling, but patients will be encouraged to continue monitoring their blood sugars and contact the investigators should they experience any problems with their glycaemic control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) > 35,
  • Insulin-requiring T2DM,
  • Age >18yr,
  • Having undergone gastric bypass surgery,
  • HbA1C >8%

排除标准

  • Non-insulin requiring T2DM,
  • HbA1C <8%

研究组 & 干预措施

Actrapid insulin

Experimental

Intensive glycaemic control Intervention: Actrapid insulin

干预措施: Actrapid insulin (Drug)

Actrapid insulin+Gloucose

Active Comparator

conventional glycaemic control Intervention: Actrapid insulin+Glucose

干预措施: Actrapid insulin+Gloucose (Drug)

结局指标

主要结局

efficacy and safety of an intensive glycaemic protocol after bariatric surgery

时间窗: 1 year

insulin+Gloucose

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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