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Report for Clinical Trial NCT00187720

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Genetic Basis for Variation in the Renal Elimination of Metformin

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent, metformin.

NCT00187720 Other Conditions That May Be A Focus of Clinical Attention

1 Interventions

Name: Metformin

Description: Subjects will be given a single oral dose of 850 mg of metformin

Type: Drug

OCT2-reference Group OCT2-variant Group


Primary Outcomes

Description: To test whether individuals with genetic variants of the human organic cation transporter, OCT2, exhibit altered renal elimination of metformin we will measure the difference in renal clearance between reference and variant groups.

Measure: Renal Clearance of Metformin

Time: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours

Allocation: Non-Randomized

Parallel Assignment


There are 4 SNPs

SNPs


1 A270S

In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with ethnic-specific allele frequencies ≥1% [6] that have altered function in studies in heterologous expression systems. --- M165I --- --- A270S ---

In addition, we identified a common haplotype of hOCT2 and one haplotype that contain the non-synonymous cSNP, A270S. --- A270S ---


2 K432Q

In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with ethnic-specific allele frequencies ≥1% [6] that have altered function in studies in heterologous expression systems. --- M165I --- --- A270S --- --- R400C --- --- K432Q ---

We will also determine whether individuals who are heterozygous for the less common OCT2 variants, M165I, R400C and K432Q, have reduced renal clearances of metformin. --- M165I --- --- R400C --- --- K432Q ---


3 M165I

In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with ethnic-specific allele frequencies ≥1% [6] that have altered function in studies in heterologous expression systems. --- M165I ---

We will also determine whether individuals who are heterozygous for the less common OCT2 variants, M165I, R400C and K432Q, have reduced renal clearances of metformin. --- M165I ---


4 R400C

In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with ethnic-specific allele frequencies ≥1% [6] that have altered function in studies in heterologous expression systems. --- M165I --- --- A270S --- --- R400C ---

We will also determine whether individuals who are heterozygous for the less common OCT2 variants, M165I, R400C and K432Q, have reduced renal clearances of metformin. --- M165I --- --- R400C ---



HPO Nodes