NCT03246828已完成不适用
Investigating Glucagon Secretion in HNF1-alpha and HNF4-alpha MODY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in plasma glucagon from baseline (0min)
研究概览
简要总结
The aim of this study is to determine whether fasting and post-prandial glucagon secretion is suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for 3 days.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HNF1-alpha or HNF4-alpha MODY.
- •Currently on gliclazide treatment
排除标准
- •Currently taking any anti-diabetic medication other than gliclazide and metformin
- •Oral steroid treatment 30 days prior to the start or at any time during the study period.
- •Known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol.
- •Felt to be unsuitable to participate in the study in the opinion of the Chief Investigator.
- •Currently participating in a clinical trial involving an anti-diabetic medication
结局指标
主要结局
Change in plasma glucagon from baseline (0min)
时间窗: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Change in the concentration of plasma glucagon from baseline during an oral glucose tolerance test (OGTT), while on gliclazide and after a washout period.
次要结局
- Continuous glucose monitor recordings(12 days)
- Change in plasma c-peptide from baseline (0min)(0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.)
- Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)(0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.)
研究者
研究点 (2)
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