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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.

Study design
This is an observational study planning to enroll 150 participants. It does not involve any interventions or treatments.
What's involved
You would provide blood samples at one or multiple times over a period of up to two years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, up to 2 years post enrollment.

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NCT07360938

Drug Interaction Potential of Pro-Inflammatory Conditions

Recruiting
Not specifiedAges 12–99Observational
Indiana University
~150 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:None (Observational)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quantification of Plasma Cytokine Concentrations
Measured over Through study completion, up to 2 years post enrollment
+4 more outcomes measured

Conditions

Diabetes Mellitus, Type 2
End Stage Renal Disease
Irritable Bowel Syndrome

Explore related trials

Chronic Kidney Disease, Stage 5Inflammatory Bowel DiseaseIrritable Bowel SyndromeType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Indiana1

Who to contact

Ross C Robinson
[email protected]
3172742744
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD
Ability to provide written informed consent and HIPAA authorization

Exclusion

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

What this trial measures

  • Quantification of Plasma Cytokine ConcentrationsThrough study completion, up to 2 years post enrollment

    The first primary objective will involve quantification of plasma cytokine concentrations from patient blood samples.

  • Phenotyping of Patient Immune CellsThrough study completion, up to 2 years post enrollment

    The second primary objective will involve phenotyping of patient immune cells from patient blood samples.

  • Quantification of the Plasma Concentrations of Endogenous Biomarkers of Drug Metabolism and TransportThrough study completion, up to 2 years post enrollment

    The third primary objective will involve quantification of the plasma concentrations of endogenous biomarkers of drug metabolism and transport from patient blood samples

  • Measures of Inflammatory Disease SeverityThrough study completion, up to 2 years post enrollment

    The fourth primary objective will involve collecting measures of inflammatory disease severity based on information collected from patients' electronic health records.

  • Development of Adverse Events Attributable to CYP/Transporter Substrate MedicationsThrough study completion, up to 2 years post enrollment

    The fifth primary objective will involve collecting the development of adverse drug events attributable to CYP/transporter substrate medications based on information collected from patients' electronic health records.