[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07360938":3,"trial-entities:NCT07360938":97,"trial-summary:NCT07360938":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":16,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":50,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":67,"locations":71,"central_contacts":87,"overall_officials":94,"references":95,"see_also_links":96},"NCT07360938","27983","Drug Interaction Potential of Pro-Inflammatory Conditions","RECRUITING","2030-12-31","2026-01","2026-01-22","2025-11-01","Indiana University","OTHER",true,"Pro-inflammatory cytokines, which are elevated in pro-inflammatory disease states (e.g., type II diabetes mellitus \\[T2DM\\], irritable bowel diseases \\[IBD\\], and end stage renal disease \\[ESRD\\]) have been shown to inhibit hepatic drug-metabolizing enzymes, including members of the cytochrome P450 (CYP) family, and drug transporters; resultantly, pro-inflammatory diseases have been demonstrated to increase the exposure and potential for adverse drug events with co-administered CYP and drug transporter substrates. However, the clinical relevance of pro-inflammatory disease-drug interactions has not been systematically evaluated. The long-term goal of this research is to establish clinical strategies to mitigate pro-inflammatory disease-drug interactions and associated adverse drug events. The specific objective of this study is to determine the clinical relevance of pro-inflammatory disease-drug interactions, including establishment of the effect of pro-inflammatory diseases on drug disposition throughout disease trajectories (i.e., determining the differential effects on drug disposition based on the severity of disease). Towards this objective, this study will investigate the extent of increases in inflammation in patients with varying severities of pro-inflammatory diseases and estimate the resulting effects on drug disposition. Cytokine\u002Fchemokine concentrations and immune cell profiles will be assayed from blood samples of adult and pediatric patients with differing severities of pro-inflammatory diseases, using established disease monitoring parameters (e.g., glycosylated hemoglobin \\[HbA1C\\] for T2DM, C-reactive protein \\[CRP\\] for IBD, proteinuria for ESRD). The effect of changes in inflammation during differing severities of these pro-inflammatory diseases on drug disposition will then be estimated using established pharmacokinetic modeling approaches (e.g., physiologically-based pharmacokinetic modeling \\[PBPK\\]).",null,[18,19,20],"Diabetes Mellitus, Type 2","End Stage Renal Disease","Irritable Bowel Syndrome",[],"OBSERVATIONAL",[],{"count":25,"type":26},150,"ESTIMATED",[28],{"type":13,"name":29,"description":30,"armGroupLabels":31},"None (Observational)","This observational study will not involve any interventions. Instead, the study will collect blood samples at one or multiple time points.",[19,20,32],"Type 2 Diabetes Mellitus",[34,38,41,44,47],{"measure":35,"description":36,"timeFrame":37},"Quantification of Plasma Cytokine Concentrations","The first primary objective will involve quantification of plasma cytokine concentrations from patient blood samples.","Through study completion, up to 2 years post enrollment",{"measure":39,"description":40,"timeFrame":37},"Phenotyping of Patient Immune Cells","The second primary objective will involve phenotyping of patient immune cells from patient blood samples.",{"measure":42,"description":43,"timeFrame":37},"Quantification of the Plasma Concentrations of Endogenous Biomarkers of Drug Metabolism and Transport","The third primary objective will involve quantification of the plasma concentrations of endogenous biomarkers of drug metabolism and transport from patient blood samples",{"measure":45,"description":46,"timeFrame":37},"Measures of Inflammatory Disease Severity","The fourth primary objective will involve collecting measures of inflammatory disease severity based on information collected from patients' electronic health records.",{"measure":48,"description":49,"timeFrame":37},"Development of Adverse Events Attributable to CYP\u002FTransporter Substrate Medications","The fifth primary objective will involve collecting the development of adverse drug events attributable to CYP\u002Ftransporter substrate medications based on information collected from patients' electronic health records.",[51],{"measure":52,"description":53,"timeFrame":37},"Patient Genomic Markers","The secondary objective will involve determining patient genomic markers (using whole genome sequencing).","ALL","12 Years","99 Years",false,{"inclusion":59,"exclusion":62,"raw_text":66},[60,61],"Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD","Ability to provide written informed consent and HIPAA authorization",[63,64,65],"Diagnosis or past medical history of non-IBD autoimmune disorder, including systemic lupus erythematosus, Sjogren's syndrome, multiple sclerosis, type 1 diabetes mellitus, Behcet's disease, and ankylosing spondylitis","Current infection requiring medical treatment (note: if a prospective patient's infection resolves, they can be re-screened for trial inclusion)","Concomitant treatment with systemic immunosuppressant drugs","Inclusion Criteria:\n\n* Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD\n* Ability to provide written informed consent and HIPAA authorization\n\nExclusion Criteria:\n\n* Diagnosis or past medical history of non-IBD autoimmune disorder, including systemic lupus erythematosus, Sjogren's syndrome, multiple sclerosis, type 1 diabetes mellitus, Behcet's disease, and ankylosing spondylitis\n* Current infection requiring medical treatment (note: if a prospective patient's infection resolves, they can be re-screened for trial inclusion)\n* Concomitant treatment with systemic immunosuppressant drugs",[68,69,70],"CHILD","ADULT","OLDER_ADULT",[72],{"facility":73,"status":7,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":84},"Indiana University Hospital","Indianapolis","Indiana","46202","United States",[79],{"name":80,"role":81,"phone":82,"email":83},"Ross Robinson","CONTACT","3172742744","rossrobi@iu.edu",{"lat":85,"lon":86},39.76838,-86.15804,[88,90],{"name":89,"role":81,"phone":82,"email":83},"Ross C Robinson",{"name":91,"role":81,"phone":92,"email":93},"Tyler A Shugg, PharmD, PhD","9856304594","tshugg@iu.edu",[],[],[],{"nct_id":4,"conditions":98,"biomarkers":101},[99,100,20,32],"Chronic Kidney Disease, Stage 5","Inflammatory Bowel Disease",[],{"nct_id":4,"found":14,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an observational study planning to enroll 150 participants. It does not involve any interventions or treatments.","completed","Understanding Drug Interactions in Inflammatory Conditions","This observational study aims to understand how inflammatory conditions like Type 2 Diabetes, Irritable Bowel Syndrome (IBS), and End Stage Renal Disease (ESRD) might affect how your body processes medications. Researchers believe that inflammation can change how certain enzymes (proteins that help break down drugs) and transporters (proteins that move drugs around the body) work, potentially leading to more side effects from your medicines. This study will collect blood samples over a period of up to two years to measure levels of inflammatory markers (cytokines), examine immune cells, and check levels of natural substances in your body related to drug processing. You may be able to join if you are between 12 and 99 years old and have been diagnosed with one of these pro-inflammatory diseases. The study is currently unclear on its recruitment status.","Participants will be followed through study completion, up to 2 years post enrollment.",135,"You would provide blood samples at one or multiple times over a period of up to two years.","Not stated in the trial record.",[],"v2"]