EXPLORING THE INTERPLAY BETWEEN VITAMIN D DEFICIENCY, ADVANCED GLYCATION END PRODUCT AND GENETIC VARIANT OF RAGE GENE IN PATIENT WITH MICROVASCAULAR COMPLICATION: AN INTERVENTIONAL STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome of this interventional study could be the change in microvascular complications (such as diabetic retinopathy, nephropathy, or neuropathy) severity or progression in patients with comorbid vitamin D deficiency, advanced glycation end product (AGE) accumulation, and a genetic variant of the RAGE gene. This could be measured using established clinical scales or diagnostic tests specific to each microvascular complication
研究概览
简要总结
This quasi-experimental , non-randomized, open-label, multicentered, single-arm non-inferiority interventional cohort trial with enrichment study investigated the effect of vitamin D supplementation on Advanced Glycation End-products (AGEs) in diabetic patients with microvascular complications. The study enrolled 150 participants divided into three groups: 50 healthy controls (Group I), 50 diabetics without complications (Group II), and 50 diabetics with complications and vitamin D deficiency (Group III). Only the intervention group (Group III) received oral Vitamin D3 supplementation for three months. The primary outcome was the change in serum AGE levels in Group III after supplementation. All participants underwent baseline measurements of Vitamin D and AGE levels, as well as genotyping for the RAGE gene variant (rs1800625). The study also aimed to analyze associations between baseline Vitamin D and AGEs, and to investigate if the RAGE genotype influenced the response to supplementation. The protocol received ethical approval and informed consent was obtained from all participants.
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
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •patient with diabetes and at least one microvascular complication and vitamin d deficiency.
排除标准
- •patient with renal diseases or other conditions affecting vitamin D metabolism, osteoporosis, increased risk of fractures, muscle weakness, and a compromised immune system, use of vitamin D supplementation within the past 3 months, any hypersensitivity to study medication or contraindication.
结局指标
主要结局
The primary outcome of this interventional study could be the change in microvascular complications (such as diabetic retinopathy, nephropathy, or neuropathy) severity or progression in patients with comorbid vitamin D deficiency, advanced glycation end product (AGE) accumulation, and a genetic variant of the RAGE gene. This could be measured using established clinical scales or diagnostic tests specific to each microvascular complication
时间窗: Serum levels of vitamin D measured in ng/mL at baseline1 week and after 3 months which might explore a new relationship between vitamin D and the microvascular complication of Diabetes mellitus
次要结局
- Change in serum levels of vitamin D before & after intervention.(Change in levels of advanced glycation end products (AGEs) in serum or affected tissues before & after intervention.)
研究者
saitharani arumugam
Chettinad Academy Of Research And Education