A Randomized, Double Blind, Placebo Controlled, Pilot Study to Evaluate ACute and Chronic Effects of Saxagliptin on Impaired Glucose Tolerance and micro-and Macro-vascular Integrators
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- oral glucose tolerance test.
研究概览
简要总结
Glucose ACCES study will explore the acute and long term (12-week treatment) effects of saxagliptin in patients with impaired glucose tolerance during fasting and after a standardised breakfast. The investigations will be performed on:
- glycemic parameters
- on cardiovascular parameters
详细描述
The aim of this pilot study is to compare in patients with impaired glucose tolerance the effects of saxagliptin versus placebo:
(i) on glucose metabolism (ii) on vago-sympathetic activity, arterial stiffness and endothelial function. A total of 36 patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, Bondy, France.
The measurements will be performed in the morning 1) at the time of randomisation (Acute ACCES study) and 2) 11-14 weeks after the beginning of saxagliptin or placebo (Chronic ACCES study).
We will evaluate at fasting and each hour after a standardized breakfast:
(i) biological and metabolic parameters. Furthermore, an oral glucose tolerance test will be performed at the end of the study.
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
- Double (Participant, Investigator)
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
- 否
入选标准
- •Social security affiliation
- •Persons without TUTORSHIP that can freely agree to participate to the study
- •Age between 18 to 70 years
- •Impaired glucose tolerance diagnosed during the previous month.
- •Exclusion criteria:
- •Pregnancy
- •Breast feeding
- •No contraception
- •Body Mass Index > 45 kg/m²
- •Arterial blood pressure > 160/110 mmHg
- •Creatinine clearance < 60 ml/min
- •Severe hepatocellular insufficiency
- •Chronic respiratory disease
- •Anaemia (Hemoglobin < 10 g/dl)
- •Peripheral arterial occlusive disease
- •Heart failure
- •Cardiac arrhythmia
排除标准
- 未提供
研究组 & 干预措施
placebo pill
at BREAKFEAST
干预措施: placebo pill (Other)
Saxagliptin
Saxagliptin 5 mg (tablet) at BREAKFEAST
干预措施: saxagliptin (Drug)
结局指标
主要结局
oral glucose tolerance test.
时间窗: First day (inclusion) and after 11-14 weeks of treatment
This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.
Vago-sympathetic activity.
时间窗: First day (inclusion) and after 11-14 weeks of treatment
This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.
arterial stiffness
时间窗: First day (inclusion) and after 11-14 weeks of treatment
This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.
endothelial function
时间窗: First day (inclusion) and after 11-14 weeks of treatment
This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.
次要结局
未报告次要终点