EXPLORING THE THERAPEUTIC POTENTIAL OF PROBIOTICS IN MODULATING GLYCEMIC LEVELS IN TYPE 2 DIABETES MELLITUS
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Self
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improved Glycemic Control: A significant reduction in HbA1c, fasting blood glucose (FBG), Postbrandial blood gulcose, HOMA-IR levels
研究概览
简要总结
Our study is a prospective interventional trial conducted over six months to evaluate the therapeutic potential of probiotics in modulating glycemic control and inflammatory status in Type 2 Diabetes Mellitus (T2DM) patients diagnosed within the last two years. A total of 50 participants with moderate glycemic control will be enrolled and divided into two groups: 25 receiving probiotics daily for 12 weeks and 25 serving as controls. The study aims to measure changes in fasting blood glucose (FBG), postprandial blood glucose (PBG), HbA1c, HOMA IR and hsCRP before and after intervention. The expected outcome is a significant reduction in glycemic markers and hsCRP in the probiotic group compared to controls, highlighting probiotics as a potential adjunct therapy in T2DM management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •* Patients above 30 and below 65 years. * Patients diagnosed with Type 2 Diabetes Mellitus within 2years * HbA1C range between 6.5%.
- •9.0% (Moderate glycemic control) * hs.
- •CRP with the range 1.0 – 10.0 mg/dL * No major changes in treatment for X 3 months. * Patients who agree to participate by knowing the objectives of the study and voluntarily participate.
排除标准
- 未提供
结局指标
主要结局
Improved Glycemic Control: A significant reduction in HbA1c, fasting blood glucose (FBG), Postbrandial blood gulcose, HOMA-IR levels
时间窗: 6 months
in the probiotic group compared to the control group.
时间窗: 6 months
Reduction in hsCRP Levels: A notable decrease in high-sensitivity C-reactive protein (hsCRP), indicating
时间窗: 6 months
reduced systemic inflammation, which is linked to better glycemic control
时间窗: 6 months
次要结局
未报告次要终点
研究者
Dr P Dhivyaprasath
Swamy Vivekanandha College of Pharmacy