Effect of genetic polymorphism on antidiabetic medication in Indian patients with Type 2 Diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/10/058414
- Lead Sponsor
- Chellaram Diabetes Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Subjects from Indian population diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association.
Subjects having with HbA1c in the range of 7.5–12% and either on monotherapy or combination therapy on antidiabetic drugs.
Subjects over 18 years old and below 60 years
Subjects who agree with the written informed consent to participate in the study
Other than Indian ethnicity
Under 18 years old
Pregnant or lactating women
Patients with malignancies, and chronic kidney disease stage 3–5, liver cirrhosis
Presently suffering from congestive heart failure requiring pharmacologic treatment (medical history)
Past history of urinary or gastric retention or narrow-angle glaucoma
Presently severe anaemia
Taking a medication that could confound study results, such as known substrates or inhibitors of OCT3 and MATE1, such as cimetidine.
They do not provide consent to participate in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Genetic association of response to anti-diabetic drugs with a particular SNP or SNPs <br/ ><br>Responders and non-responders based on HbA1c % (less than 7% and above 7%) - allele frequency of each SNP <br/ ><br>Timepoint: 0 month <br/ ><br>3 months <br/ ><br>6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Information on genetic polymorphism and variant allele frequency at the studied loci in the study population will be obtained. <br/ ><br>Development of a SNP Genotyping assay for pharmacogenomic assessment of T2D patients. <br/ ><br>Development of matrix for treatment decision based on the pharmacogenomic information. <br/ ><br>Timepoint: After 6 months