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临床试验/CTRI/2024/02/063321
CTRI/2024/02/063321尚未招募不适用

Evaluation of emerging inflammatory biomarkers in T2DM subjects across BMI spectrum.

MAHE Manipal1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2024年3月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
85
试验地点
1
主要终点
Correlation between target analytes and biochemical and metabolic markers

研究概览

简要总结

Diabetes affects 422 million people globally, with the majority living in low- and middle-income countries. It is a carbohydrate metabolism disorder characterized by hyperglycemias, insulin resistance, and altered lipid and amino acid metabolism. Diagnosis tests include fasting sugar >126mg/dL, HbA1c >6.5%, and random blood sugar >200 mg/dL. Long-term consequences include microvascular complications like retinopathy and neuropathies, and macrovascular complications like cardiovascular diseases and stroke. Chronic systemic low-grade inflammation is key to the pathogenesis and progression of type 2 diabetes mellitus. Obesity is the main risk factor for the initiation and progression of T2DM and other metabolic syndrome spectrum disorders. The Activin A-Follistatin system has emerged as a potential predictor of inflammation and homeostasis of glucose and lipids, showing promise as a risk stratification index or prognostic marker of T2DM progression. This study aims to explore circulating levels of activin A, follistatin, and the activin A: follistatin ratio in T2DM patients with normal BMI and compare them with overweight T2DM patients. It also aims to correlate the above inflammatory markers with biochemical and haematological markers, along with determining effect of comorbidities and lifestyle on these inflammatory markers.

Understanding the role of activin A, follistatin, and activin A: follistatin ratio in obesity, inflammation, glycemic status, and lipid homeostasis in T2DM patients can provide insights into inflammatory status, guide early anti-inflammatory therapy introduction, and assess the effects of dietary, lifestyle, and psychosocial interventions.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Cases: Newly diagnosed cases of T2DM within 5 years of diagnosis, not on insulin, without any secondary complications of diabetes mellitus, will be included in the study.
  • Controls: Healthy individuals coming for routine health check up will be evaluated and recruited as controls.

排除标准

  • Cases: Patients diagnosed with diabetes for a period of more than 5 years or patients with advanced micro and macrovascular complications of diabetes, or patients on insulin injections will be excluded from the study.
  • Controls: Patients diagnosed with diabetes, thyroid disorders, or any other chronic lifestyle diseases (except hypertension), patients with acute infective illness, and patients on drugs that might alter glucose homeostasis (such as corticosteroids), trauma patients, and pregnant women will be excluded from the study.

结局指标

主要结局

Correlation between target analytes and biochemical and metabolic markers

时间窗: At baseline

次要结局

  • Correlation of target analyses with BMI & HbA1c(At baseline)

研究者

发起方
MAHE Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ayeshani Mishra

Kasturba Medical College

研究点 (1)

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