Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- mean amplitude of glycemic excursions( MAGE)
研究概览
简要总结
The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.
详细描述
This study was a single-center, randomized, controled and prospective trial. Type 2 diabetic patients were randomized into 2 groups (Group A and Group B). Subjects in group A would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group B would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets). After achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days. Then a Medtronic dynamic blood glucose meter would be applied to the subjects for 72 hours. The clinical data, such as demographic information, present history, past history, personal history and so on were collected in the 1st day. In the 2nd day and the last day of the trial, the blood samples of the patient were collected for the Laboratory Measurements: Cr, uric acid, aminotransferase, lipid profiles, white blood cell count, N%, fasting plasma glucose, fasting C-peptide, insulin, HbA1c and standard meal test (0.5h-postprandial and 2h-postprandial blood glucose levels, C peptide and insulin, et al. The parameters of b-cell function and glycemia fluctuation were calculated and then analyzed by spss 13.0.
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
- •diagnosed as type 2 diabetes in the first time without drug therapy, or type 2 diabetes does not accept insulin in the near 3 month and duration is shorter than 10 years
- •Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
- •agree to participate the study and sign the informed consent.
排除标准
- •obvious failure of heart, hepatic, kidney function.
- •severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
- •women in pregnancy or planning to get pregnancy.
研究组 & 干预措施
GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg.
干预措施: insulin lispro (Drug)
GROUP B
using glargine combined with oral drugs: insulin glargine, Lantus( initiating with 0.2 IU/kg) with metformin hydrochloride, Glucophage 500mg bid and gliclazide modified release tablets, Diamicron modified release(MR) tablets 60mg qd.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
mean amplitude of glycemic excursions( MAGE)
时间窗: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data.
次要结局
- glycated albumin(From date of randomization until the end of study, assessed up to 15 days)
- Fasting insulin(From date of randomization until the end of study, assessed up to 15 days)
- Homa-β(From date of randomization until the end of study, assessed up to 15 days)
- insulin secretion-sensitivity index(From date of randomization until the end of study, assessed up to 15 days)
- disposition index(From date of randomization until the end of study, assessed up to 15 days)
- standard deviation of glucose level(during three days' CGMS)
- fasting plasma glucose, postprandial plasma glucose (30min, 120min)(From date of randomization until the end of study, assessed up to 15 days)
- Fasting C-peptide(From date of randomization until the end of study, assessed up to 15 days)
- glycated hemoglobin A1c(From date of randomization until the end of study, assessed up to 15 days)
- area under curve (AUC) when the glucose level was higher than 7.8mmol/L(during three days' CGMS)
- area under curve (AUC) when the glucose level was lower than 3.9mmol/L(during three days' CGMS)
- thiobarbituric acid reactive substance(From date of randomization until the end of study, assessed up to 15 days)
- the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)(From date of randomization until the end of study, assessed up to 15 days)
研究者
Longyi Zeng
Head of Endocrinology and Metabolism department
Third Affiliated Hospital, Sun Yat-Sen University