Drug Interaction Potential of Pro-Inflammatory Conditions Observational Study in Patients with Type 2 Diabetes, Irritable Bowel Disease, and End Stage Renal Disease

What this Trial Is About

This research aims to understand how pro-inflammatory diseases like type 2 diabetes mellitus (T2DM), irritable bowel diseases (IBD), and end stage renal disease (ESRD) affect the way the body processes medications. The study focuses on how inflammation in these conditions might increase drug levels and the risk of side effects by interfering with enzymes and transporters important for drug metabolism. Researchers want to determine how disease severity influences these drug interactions and to develop strategies to reduce related adverse events. The study is observational and involves collecting blood samples from adults and children aged 12 to 99 with different severities of these pro-inflammatory diseases. Blood tests will measure cytokines, chemokines, immune cell profiles, and biomarkers indicating drug metabolism and transport. Disease severity will be monitored using established clinical markers like HbA1C for diabetes, C-reactive protein for IBD, and proteinuria for ESRD. Data from these samples will be analyzed using pharmacokinetic models to estimate how inflammation changes drug behavior. Participants will be involved for up to two years after enrollment during which plasma cytokine levels, immune cell types, biomarkers of drug metabolism, and disease severity will be regularly measured. Researchers will also track any adverse events linked to medications processed by affected enzymes or transporters. Genetic markers of participants will be studied as secondary outcomes. The study does not involve any treatments but focuses on monitoring and assessing biological samples to better understand disease-drug interactions over time.

Drug Interaction Potential of Pro-Inflammatory Conditions