A Gut-Targeted Synbiotics with Vildagliptin–Metformin in Elderly Type 2 Diabetes: Impact on Glycemic Control, Oxidative Stress, Inflammatory Respnse and Insulin Sensitivity – An Open-Label Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Reduction of Serum Glucose level and HbA1C level
研究概览
简要总结
Synbiotics may have a particular application in elderly populations, especially in terms of protection against infections, inflammation, oxidative stress and also in the prevention of several age-related diseases. Synbiotic agents along with vildagliptin reduce the glucose level, inflammation and oxidative stress in geriatric population with Type 2 diabetes mellitus and also synbiotics potentiate the action of DPP4 inhibitors Metformin is the conventional drug irrespective of age group and it prevents the gut leakage and reduce the gut inflammation. The role of synbiotic agents along with Vildagliptin and Metformin in geriatric population with Type 2 Diabetes Mellitus is not done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group- 60- 85 years Both the genders Diagnosed with type 2 diabetes mellitus patients HbA1c level between 7 to 8% Diabetes with or without hypertension Diabetes with or without dyslipidaemia.
排除标准
- •Diabetes with renal failure Diabetes with liver failure Age below 60 years.
结局指标
主要结局
Reduction of Serum Glucose level and HbA1C level
时间窗: Reduction of Serum Glucose level and HbA1C level
次要结局
- Reduction of Inflammation and Oxidative Stress and Insulin sensitivity(3 months)
研究者
Kala P
Department of Pharamcology SRM Medical College Hospital and Research Centre