The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- NHS Tayside
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- HbA1c reduction
研究概览
简要总结
The study hypothesis is that people who respond well to sulphonylureas have a different underlying cause for their diabetes than people who respond poorly to this medication. We are using two approaches to study this. In one approach we look at people who have previously responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and then looking at how well they produce insulin in response to glucose and an intravenous sulphonylurea called tolbutamide. The second approach identifies people with a certain genetic predisposition to diabetes (due to changes in the TCF7L2 gene) and then looks at how well they respond to sulphonylurea medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Age >35 and < 70
- •Age of diabetes diagnosis >35 and <70
- •White European
- •Pre-SU HbA1c <=10%
- •HbA1c (on treatment) <= 9%
- •No myocardial infarction or Acute coronary syndrome in previous year
- •No stroke or transient ischaemic attack in previous year
- •No or stable (background) retinopathy (no unscheduled laser treatment in the last 6 months)
- •eGFR > 60mls/min
- •No Proteinuria >30mg/dl on multistix 10SG
- •No active foot ulceration or infection
- •Liver ALT ≤ twice the upper limit of the reference range
- •Contactable by telephone
排除标准
- •Type 1 diabetes
- •HbA1c >10% prior to commencing SU
- •HbA1c>9% on SU treatment
- •Recent MI or Stroke within last 12 months
- •Pre-proliferative or proliferative retinopathy
- •eGFR<60 ml/min
- •Proteinuria >30mg/dl on multistix 10SG
- •Active foot ulceration or infection
- •Liver ALT > twice the upper limit of the reference range
- •Female planning to conceive within the study period
- •Any other significant medical reason for exclusion as determined by the investigator
研究组 & 干预措施
1
Withdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c
干预措施: gliclazide (Drug)
结局指标
主要结局
HbA1c reduction
时间窗: 6 weeks
次要结局
- insulin secretory response to glucose and tolbutamide(acute)
研究者
Ewan Pearson
Professor of Diabetic Medicine
NHS Tayside