Diabetes Mellitus, Type 2DIPPICNCT07360938
Drug Interaction Potential of Pro-Inflammatory Conditions
An observational study of Diabetes Mellitus, Type 2 and End Stage Renal Disease, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, End Stage Renal Disease, Irritable Bowel Syndrome
- What is being tested?
- None (Observational)
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a prospective observational study that will collect blood samples at 1-3 timepoints per patient. The study will not include any therapeutic intervention, and no study visits will involve patient interaction with the health system solely for study participation. The study will enroll up to 150 patients. All enrolled patients will undergo the study procedures, which will enable quantification of plasma cytokine concentrations and immune cell profiles at 1-3 timepoints.
Who may be able to join
- Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD
- Ability to provide written informed consent and HIPAA authorization
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Hospital
Indianapolis, Indiana, 46202
Ross Robinson, 3172742744, rossrobi@iu.edu
About this study
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]).
- Being tested
- None (Observational)
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational)Other
This observational study will not involve any interventions. Instead, the study will collect blood samples at one or multiple time points.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus | Not described Receives: Other: None (Observational) | |
| End Stage Renal Disease | Not described Receives: Other: None (Observational) | |
| Irritable Bowel Syndrome | Not described Receives: Other: None (Observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Plasma Cytokine Concentrations
The first primary objective will involve quantification of plasma cytokine concentrations from patient blood samples.
Measured: Through study completion, up to 2 years post enrollment
Phenotyping of Patient Immune Cells
The second primary objective will involve phenotyping of patient immune cells from patient blood samples.
Measured: Through study completion, up to 2 years post enrollment
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
Measured: Through study completion, up to 2 years post enrollment
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.
Measured: Through study completion, up to 2 years post enrollment
Development of Adverse Events Attributable to CYP/Transporter Substrate Medications
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.
Measured: Through study completion, up to 2 years post enrollment
Secondary outcomes (1)
Patient Genomic Markers
The secondary objective will involve determining patient genomic markers (using whole genome sequencing).
Measured: Through study completion, up to 2 years post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Andrew Shugg, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360938
- Sponsor's protocol ID
- 27983
- Acronym
- DIPPIC
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There are Material Transfer Agreements and Data Use Agreements in place to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interaction Potential of Pro-Inflammatory Conditions
- ClinicalTrials.gov ID
- NCT07360938
- Acronym / sponsor ID
- DIPPIC / 27983
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus | – | Other: None (Observational) |
| End Stage Renal Disease | – | Other: None (Observational) |
| Irritable Bowel Syndrome | – | Other: None (Observational) |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a prospective observational study that will collect blood samples at 1-3 timepoints per patient. The study will not include any therapeutic intervention, and no study visits will involve patient interaction with the health system solely for study participation. The study will enroll up to 150 patients. All enrolled patients will undergo the study procedures, which will enable quantification of plasma cytokine concentrations and immune cell profiles at 1-3 timepoints.
Key inclusion criteria (2 listed)
- Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD
- Ability to provide written informed consent and HIPAA authorization
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational)This observational study will not involve any interventions. Instead, the study will collect blood samples at one or multiple time points. | Other | End Stage Renal Disease, Irritable Bowel Syndrome, Type 2 Diabetes Mellitus |
Primary outcome
Quantification of Plasma Cytokine Concentrations
Time frame: Through 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 Cells
Time frame: Through 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 Transport
Time frame: Through 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 Severity
Time frame: Through 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 Medications
Time frame: Through 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.
1 secondary outcome
Patient Genomic Markers
Time frame: Through study completion, up to 2 years post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes. There are Material Transfer Agreements and Data Use Agreements in place to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and End Stage Renal Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ross C Robinson (3172742744, rossrobi@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Plasma Cytokine Concentrations (time frame: Through study completion, up to 2 years post enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.