How inflammatory diseases change the way your body handles medicines.
Drug Interaction Potential of Pro-Inflammatory Conditions
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 12 Years to 99 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07360938 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana
- Indiana University Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Ross C Robinson
- Email: rossrobi@iu.edu
- Phone: 3172742744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.