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临床试验/CTRI/2025/10/096395
CTRI/2025/10/096395招募中不适用

Evaluation of sirt1 and sirt4 gene expression in circulating leukocytes in type 2 diabetes mellitus in western Uttar Pradesh

Government Institute of Medical Sciences (GIMS)1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年10月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
1
主要终点
To compare the gene expression levels of SIRT1 and SIRT4 between T2DM patients and

研究概览

简要总结

  1. Background of the study • Type 2 Diabetes Mellitus (T2DM) is a global health challenge, affecting over 589 million adults, with rising prevalence.1 • SIRT1 and SIRT4 are key metabolic regulators involved in insulin sensitivity, inflammation, and mitochondrial function2 • Studies suggest downregulation of SIRT1 and SIRT4 in patients with T2DM.3 • This study aims to evaluate SIRT1 and SIRT4 gene expression in peripheral blood leukocytes and assess their involvement in T2DM pathophysiology. • During Fasting,calorie restriction,NAD levels in the cell increses which leads activation of SIRT 1 gene causes deacetylation of certain factors like p53,FOX01,PGC1 alpha,NF-kB which causes enhanced mitochondrial function,increase stress resistance,suppression of apoptosis,anti-inflammatory effects leads to anti aging effects,metabolic balance and longetivity.3 • SIRT4 gene expression leads to transcription and translation into SIRT4 protien,SIRT4 act as mitochondrial enzyme regulator which has ADP ribosyl transferase,lipoamidase,deacylase.Due to these enzyme activity,it inhibits Glutamate Dehydrogenase(GDH) further reduces conversion of glutamate to alpha ketoglutarate.This leads to ADP/ATP ration modulation and downregulate insulin secretion and improves glucose tolerance.4

研究设计

研究类型
Observational

入排标准

年龄范围
35.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adults aged between 35 to 60 years.
  • 1.Diagnosed cases of uncontrolled Type 2 Diabetes Mellitus as per ADA criteria and with HbA1c levels greater than or equal 7 percent will be collected from dept of Medicine.
  • 2.Willing to provide written informed consent.
  • 3.For control group: age- and sex-matched apparently healthy individuals without a history of diabetes.

排除标准

  • 1.Patients with Type 1 Diabetes Mellitus or other forms of secondary diabetes.
  • 2.Individuals with acute or chronic infections, inflammatory diseases, hypertension or malignancies.
  • 3.Patients with renal disease, liver disease, or recent cardiovascular disease, smocker.
  • 4.Pregnant or lactating women.
  • 5.Individuals on immunosuppressive therapy or antioxidant supplements, lipid lowering drugs.

结局指标

主要结局

To compare the gene expression levels of SIRT1 and SIRT4 between T2DM patients and

时间窗: At the time of Enrollment only

apparently healthy controls

时间窗: At the time of Enrollment only

次要结局

  • 1. To assess biochemical parameters including insulin,Superoxide dismutase 2,Interleukin 4(,HOMA-IR in T2DM patient & apparently healthy controls.)

研究者

发起方
Government Institute of Medical Sciences (GIMS)
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ijen Bhatacharya

Government Institute of Medical Sciences (GIMS)

研究点 (1)

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