Influence of SLC22A1 480C to G and CYP2C93 1075A to C genetic polymorphisms on poor response to metformin and glimepiride combined therapy in South Indian Type 2 Diabetes Mellitus (T2DM) patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To study the association between SLC22A1 GG and CYP2C9 1075 AA genotypes and poor response to metformin glimepiride combined therapy in Type 2 Diabetes Mellitus patients of south Indian origin
研究概览
简要总结
This study is being conducted to analyze the influence of SLC22A1 480 C TO G and CYP2C93 1075 A TO C genetic polymorphisms on poor response to metformin and glimepiride combined therapy in patients with type 2 diabetes mellitus from southern India. The current prevalence of Diabetes mellitus is around 101 million in India. Type 2 diabetes accounts for 87% to 91% of the global burden of diabetes. Hence it is of paramount importance to study the genetic factors which may lead to poor response to anti diabetic treatment which may contribute to the increasing morbidity due to diabetes. If positive associations are found between the above mentioned genetic polymorphisms and poor response to diabetes treatment, we can then formulate dose modifications for the selected patients, which will lead to better treatment outcomes. This will lead to a reduction in the burden of diabetes on our healthcare system and the society as whole.
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
- •Cases Patients started on metformin and glimepiride therapy who are on a stable drug regimen for at least 6 months and reached the maximum tolerated dose and or required other addon antidiabetic drug and their Hb1Ac cutoff more than equal to 8 Patients with type 2 diabetes mellitus of South Indian origin.
- •South Indian origin is defined as patients with history of three generations living in any of the southern states namely Puducherry Tamil Nadu Kerala Karnataka Andhra Pradesh and Telangana and speaking the respective local language as mother tongue Both male and female gender Age 30 years and above Controls Patients who are on a stable drug regimen for at least 6 months started on metformin and glimepiride and reached the maximum tolerated dose and other addon antidiabetic drug in addition to above two drugs and their Hb1Ac less than 8 Patients with type 2 diabetes mellitus of South Indian origin.
- •South Indian origin is defined as patients with history of three generations living in any of the southern states namely Puducherry Tamil Nadu Kerala Karnataka Andhra Pradesh and Telangana and speaking the respective local language as mother tongue Both male and female gender Age 30 years and above.
排除标准
- •Cases Patients with a history of clinically proven renal or hepatic impairment Patients taking cationic medications like cimetidine furosemide nifedipine Drugs inhibiting CYP2C9 like Ketoconazole Phenytoin Amiodarone Fluoxetine Drugs enhancing CYP2C9 Rifampicin Carbamazepine Primidone Pregnancy and lactation Patients who regularly consume alcohol Patients who diagnosed to have type 1 diabetes, maturity onset diabetes of the young and secondary causes due to endocrinopathies or chronic intake of steroidal drugs Controls Patients with a history of clinically proven renal or hepatic impairment Patients taking cationic medications like cimetidine furosemide nifedipine Drugs inhibiting CYP2C9 like Ketoconazole Phenytoin Amiodarone Fluoxetine Drugs enhancing CYP2C9 like Rifampicin Carbamazepine Primidone Pregnancy and lactation Patients who regularly consume alcohol Patients who diagnosed to have type 1 diabetes or maturity onset diabetes of the young and secondary causes due to endocrinopathies chronic intake of steroidal drugs.
结局指标
主要结局
To study the association between SLC22A1 GG and CYP2C9 1075 AA genotypes and poor response to metformin glimepiride combined therapy in Type 2 Diabetes Mellitus patients of south Indian origin
时间窗: This will be assessed at baseline.
次要结局
- To study the effect of combined gene gene interaction of SLC22A1 480 C to G & SLC22A1 rs622342 & CYP2C93 1075 A to C affecting dose requirement of metformin & glimepiride combination therapy(Thus will be done 6 months after the beginning of patient recruitment.)
研究者
Aditya V Reddy
Jawaharlal institute of post graduate medical education and research Puducherry