How inflammatory diseases change the way your body handles medicines.
Official title: Drug Interaction Potential of Pro-Inflammatory Conditions
Run by Indiana University · NCT07360938 · Data updated 2026-11-12
This study will see if inflammatory conditions like type 2 diabetes, IBD, or end-stage kidney disease change how common medicines are processed and increase the chance of side effects.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years to 99 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT07360938 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with type 2 diabetes, inflammatory bowel disease, or end-stage renal disease who can give informed consent and are not taking systemic immunosuppressants are ideal candidates.
✕Probably not a fit
Patients with non-IBD autoimmune disorders, active infections, or on systemic immunosuppressant therapy are excluded and unlikely to benefit from participation or the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study enrolling adults with pro-inflammatory conditions (type 2 diabetes, inflammatory bowel disease, or end-stage renal disease) to measure inflammatory markers and drug handling. Investigators will compare drug-metabolizing enzyme and transporter activity and drug exposure in these patients, using blood sampling and clinical data rather than experimental drug interventions. Patients with non-IBD autoimmune diseases, active infections, or on systemic immunosuppressants are excluded to limit confounding. The study is performed at Indiana University Hospital and aims to inform clinical dosing strategies.
Why it matters
Potential benefit: If successful, the findings could help clinicians adjust medication dosing to reduce adverse drug events in patients with inflammatory diseases.
How similar studies have gone: Laboratory and limited clinical reports have shown inflammatory cytokines can suppress CYP enzymes and raise drug levels, but systematic clinical evaluation across these diseases is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD * Ability to provide written informed consent and HIPAA authorization Exclusion Criteria: * 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
Where it's running
-
Indiana University Hospital
Indianapolis, Indiana, United States Recruiting
Study contacts
- Study coordinator: Ross C Robinson
- Email: rossrobi@iu.edu
- Phone: 3172742744
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.