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NCT07360938 · ClinicalTrials.gov registry record
Drug Interaction Potential of Pro-Inflammatory Conditions
A clinical trial of Diabetes Mellitus, Type 2 and End Stage Renal Disease, sponsored by Indiana University.
- Recruiting
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT07360938 is a study of Diabetes Mellitus, Type 2 and End Stage Renal Disease that is actively recruiting participants, run by Indiana University. The registered enrollment target is 150 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07360938, a study of Diabetes Mellitus, Type 2 and End Stage Renal Disease, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
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/chemokine 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 \[PBPK\]).
Conditions Studied
Interventions
- OTHER None (Observational)
Study Locations (1)
Indiana
- Indiana University Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2030-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07360938
The ClinicalTrials.gov registry entry for NCT07360938 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which None (Observational) is the first listed.
NCT07360938 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT07360938 about?
NCT07360938 is a clinical study titled "Drug Interaction Potential of Pro-Inflammatory Conditions". 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 ...
What is the current status of trial NCT07360938?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2025-11-01. Estimated completion is 2030-12-31.
What conditions does trial NCT07360938 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, End Stage Renal Disease, Irritable Bowel Syndrome.
What interventions are being tested in trial NCT07360938?
The interventions under investigation include: None (Observational) (OTHER).
Who is sponsoring clinical trial NCT07360938?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07360938 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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