Interplay of insulin resistance, signaling disruption and inflammatory pathways in Type 2 diabetes mellitus: A cross-sectional analysis of circulatory biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Circulatory levels of Insulin, IRS-1, hsCRP and IL-6 in patients with T2DM stratified by UKPDS risk categories for macrovascular complications. Findings will help to identify the high-risk individuals, even before complications occur.
研究概览
简要总结
From existing literature on Type 2 DM, it is understood that with the development of insulin resistance there is an impairment in insulin sensitivity due to dysfunctional IRS-1 gene. Previous literature have also found that inflammatory mediators such as hsCRP and IL-6 interfere with the insulin signaling pathway by various mechanisms. However, there were discrepancies in independent studies done to find a link between IRS-1, hsCRP and IL-6 and the development of macrovascular complications in Type 2 DM. We hypothesize that there is a significant difference in insulin resistance markers, IRS-1 dysfunction, and inflammatory proteins such as hsCRP and IL-6 across UKPDS stratified risk categories in Type 2 DM patients and thus hope to develop a prediction model for cardiometabolic risk factors in these patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult T2DM patients with atleast 2 years duration of Type 2 diabetes under treatment with oral anti-diabetic agents and/ or insulin.
排除标准
- •Patients with preexisting macrovascular conditions, severe illness such as malignancy, severe infection, renal disease, respiratory disease, liver disease, impairment of speech, hearing, vision, or cognition, suffering from a serious diabetes complication, continuous or periodic use of corticosteroids; patients with type 1 presentation or continuous requirement of insulin within 1 year of diagnosis, pregnant females or those who had given birth within the preceding 6 weeks, or any medical condition that prevented participants from adhering to the protocol, lack of approval by physician and patients showing disinterest or refusal to sign the consent form.
结局指标
主要结局
Circulatory levels of Insulin, IRS-1, hsCRP and IL-6 in patients with T2DM stratified by UKPDS risk categories for macrovascular complications. Findings will help to identify the high-risk individuals, even before complications occur.
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Rachana S Menon
All India Institute of Medical Sciences, Rajkot