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临床试验/CTRI/2025/11/097215
CTRI/2025/11/097215尚未招募不适用

Influence of SLC22A1 rs628031 and KCNJ11 rs5219 genetic polymorphisms on poor therapeutic response to metformin and glimepiride combined therapy in Type 2 Diabetes Mellitus (T2DM) patients belonging to South India.

INTRAMURAL RESEARCH FUND COMMITTEE JIPMER1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年11月25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
240
试验地点
1

研究概览

简要总结

This is a case-control pharmacogenetic study for evaluating whether SLC22A1 rs628031 and KCNJ11 rs5219 genetic polymorphisms predict poor glycemic response to metformin and glimepiride combined therapy in type 2 diabetes mellitus patients belonging to south India.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • A) For Cases
  • Patients started on metformin and glimepiride therapy who are on a stable drug regimen for atleast 6 months and reached the maximum tolerated dose and or or required other add-on antidiabetic drug and their Hb1Ac levels more than 7 percent.
  • Patients with type 2 diabetes mellitus of South Indian origin.
  • South Indian origin is defined as patients with a history of three generations living in any of the southern States (Puducherry, Tamil Nadu, Kerala, Karnataka, Andhra Pradesh and Telangana) and speaking the respective local language as their mother tongue.
  • Both male and female gender.
  • Age 30 years and above.
  • B) For Controls
  • Patients who are on a stable drug regimen of metformin, glimepiride for atleast 6 months and their Hb1Ac levels less than or equal to 7 percent.

排除标准

  • A) For Cases
  • Poor adherence to combination therapy ( adherence rate of less than 90 percent will be considered as poor adherence).
  • Patients with a history of clinically proven renal or hepatic impairment.
  • Patients taking cationic medications like cimetidine, furosemide, nifedipine.
  • Pregnancy and lactation.
  • Patients who regularly consume alcohol [more than 4 standard drinks per day(1 standard drink equals to 10g of pure alcohol)].
  • Patients who diagnosed to have type 1 diabetes, maturity-onset diabetes of the young (MODY), and secondary causes due to endocrinopathies, and chronic intake of steroidal drugs.
  • B) For Controls
  • Patients who regularly consume alcohol [more than 4 standard drinks per day (1 standard drink equals to 10g of pure alcohol)
  • Patients who are diagnosed to have type 1 diabetes, maturity-onset diabetes of the young (MODY) and secondary causes due to endocrinopathies, and chronic intake of steroidal drugs.

研究者

发起方
INTRAMURAL RESEARCH FUND COMMITTEE JIPMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr R Kesavan

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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