CTRI/2024/02/062511已完成不适用
Diabetic Retinopathy Microbiome Study-India (DRMS-India)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Gut microbiome index for diabetic retinopathy
研究概览
简要总结
DRMS is a pan-India project evaluating gut microbiome of Indians living in India with diabetes mellitus or diabetic retinopathy . Earlier studies have shown differences in diversity and abundance of the gut microbiome in people with or without DM, but in a lower sample size and in restricted ethnicity . DRMS-India would overcome these deficits and would also compare with healthy controls . It will create a biomarker for diabetic retinopathy
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Type 2 DM attending OPD of the institute with DM of onset at 30 years or older (WHO criteria).
- •2.Both insulin and OHA users 3.Morbidities associated with DM, CKD (chronic kidney disease), HTN (Hypertension), CAD (coronary artery disease), CVD (Cerebral vascular disease) and dyslipidemia with or without drug usage.
排除标准
- •Chronic health disorders other than those listed in inclusion.
- •2.Usage of oral drugs in the last 3 months for a period longer than a week 3.Usage of commercially marketed pre and probiotic dietary supplements in last 1 month 4.Any use of systemic antibiotic in the last one month.
结局指标
主要结局
Gut microbiome index for diabetic retinopathy
时间窗: 3 months
次要结局
- Regional variation in gut microbiome in diabetic retinopathy across India(3 years)
研究者
DrBrijesh Takkar
L V Prasad Eye Institute
研究点 (1)
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