The Assessment of the Effect of Metformin and Its Serum Concentration on the Concentration of Substances Associated With the Production of Nitric Oxide in Patients With Impaired Carbohydrate Metabolism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Serum Levels of Metformin at Different Time Points
研究概览
简要总结
This study evaluates the effect of different doses of metformin on the function of endothelium in people with pre-diabetes. One group of the patients will receive metformin in dose: 1500 mg, the second one will receive 3000 mg/day.
The parameters from healthy volunteers will be taken only at the study beginning to compare the test results with the parameters from patients with pre-diabetes. This group will be not treated with metformin (no intervention)
详细描述
In addition to exercise and diet, metformin is a medicine used to treat diabetes mellitus (DM) and pre-diabetic (pre-DM) conditions. This drug improves insulin sensitivity in both groups of patients (DM and pre-DM) and as a result gives a reduction in blood glucose.
However, studies also confirm the effect of metformin on the reduction of cardiovascular risk in patients with diabetes (UKPDStudy), regardless of the hypoglycaemic effect.
The precise mechanism of action of the drug in this field is not clear. There is also no data on whether similar effects apply to patients with pre-diabetes. Although we know that this group of patients is also characterized by increased cardiovascular risk.
One of the most important substances that are involved in vasodilation is nitric oxide (NO). Impairment of its secretion is an important signal of endothelial damage and is connected with cardiovascular complications.
The impact of metformin on endothelial function in pre-diabetes patients is not known. We do not know the effect of the drug dose and its different serum concentration on the secretion of the dilators of the vessels, which are associated with endothelial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
At the beginning of the study, patients are assigned a number by a nurse and are assigned to group A or B according to ID. When analyzing the results, the researchers only knows the numbers of blood samples.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
group A
metformin dose 3 x 500 mg
干预措施: Metformin (Drug)
group B
metformin dose 3 x 1000 mg
干预措施: Metformin (Drug)
结局指标
主要结局
Serum Levels of Metformin at Different Time Points
时间窗: 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start
the serum concentration of the studied drug-metformin
Serum Levels of Arginine at Different Time Points
时间窗: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start
arginine serum concentration
Serum Levels of ADMA at Different Time Points
时间窗: before study start; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start
ADMA- asymmetric dimethylarginine-serum concentration
Serum Levels of SDMA at Different Time Points
时间窗: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start
SDMA-symmetric dimethylarginine-serum concentration
Serum Levels of Citrulline at Different Time Points
时间窗: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start
serum concentration of the citrulline
Serum Levels of DMA at Different Time Points
时间窗: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start
DMA- dimethylamine, serum concentration
次要结局
未报告次要终点
研究者
Edyta Sutkowska
MD, PhD; The Head of the Department and Division of Medical Rehabilitation
Wroclaw Medical University