Effect of Vildagliptin Versus Glimepiride on Copeptin and Fetuin-A in Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Copeptin Concentration (pg/ml)
研究概览
简要总结
The aim of this study is to evaluate the effect of vildagliptin on copeptin in comparison to glimepiride, and whether copeptin could be used as a marker for the efficacy of vildagliptin in type 2 diabetes mellitus patients, and how copeptin correlates with other diabetic and cardiac markers.
详细描述
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participants agreed to take part in this clinical study and provide informed consent.
- Patients with uncontrolled DM type 2 who are on metformin will be enrolled from endocrinology clinic at Damanhour general hospital.
- Serum samples will be collected for measuring the biomarkers.
- All enrolled patients will be divided into two groups; both groups will be patients who are uncontrolled and already on metformin, group I will receive vildagliptin as an add-on therapy while group II will receive glimepiride.
- All patients will be followed up during 12 week period.
- At the end of the 12 week period, serum samples will be recollected for measuring the biomarkers after treatment.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 12 weeks.
- Results, conclusion, discussion and recommendations will be given. Methodology
- Copeptin and NT-proBNP will be determined by ELISA.
- Lipid profile will be measured.
- Fasting blood glucose and Insulin will be measured and HOMA-IR will be calculated for all subjects.
- Body weight and blood pressure will be measured.
- HbA1C will be measured.
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)
盲法说明
Double Blind
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vildagliptin
Group I (N=35) are patients who the endocrinologist prescribed them Vildagliptin 50mg /tab plus their Metformin 500mg /tab once daily for 12 weeks to control their blood sugar level.
干预措施: Vildagliptin 50 MG (Drug)
Glimepiride
Group II (N=35) are patients who the endocrinologist prescribed them Glimepiride 3mg / tab plus Metformin 500mg /tab once daily for 12 weeks.
干预措施: Glimepiride 3 Mg Oral Tablet (Drug)
结局指标
主要结局
Copeptin Concentration (pg/ml)
时间窗: 3 month
Copeptin serum Level
NT-proBNP Concentration (pg/ml)
时间窗: 3 Months
NT-proBNP serum Level
次要结局
- Fasting blood glucose (mg/dl)(3 month)
研究者
Rehab Werida
Associate Professor
Damanhour University