DiabetesIPGx RegistryNCT06726590
Interprofessional Pharmacogenomics (IPGx) Registry and Repository
An observational study of Diabetes and Cholesterol, run by Texas A&M University at 1 site in United States.
Trial summary
This program collects genetic and health information to help doctors choose the right medications for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Cholesterol, Cancer
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to Nov 2029
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Texas A\&M Health clinical programs.
Who may be able to join
- The study will invite patients who are eligible for PGX workup/PGX care to participate, provided they meet the following criteria: Use of five or more medications, including over the counter drugs, supplements, natural products, cannabis products, or other recreational drugs, or
- Individuals taking blood pressure or depression medications, even if less than five medications.
- Ability to understand and give consent.
- Able to consent to donate blood and/or urine samples and buccal swabs.
- Able to answer detailed questionnaires, including quarterly questionnaires about ADRs, cognitive testing such as serial mini-mental status exams, and or quality of life questions.
- Able to understand that their health record and changes in health status will be followed for a five-year period and shared in deidentified form with the research community.
- All genders.
- Any age over 18 years.
Who cannot join
- Individuals admitted to hospice.
- Declines to participate or interact with staff/share their medical status.
- A diagnosis of Alzheimer's disease or related dementias in a medical record as this indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning.,
- Individuals who are unable or unwilling to provide consent.
- Unable to verbally communicate and comprehend English language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rick Silva, PhD contact
United States1 site, 1 recruiting
- Recruiting
Texas A&M Family Care
Bryan, Texas, 77802
Sara Rogers, PharmD, 979.776.8440, sararogers@tamu.edu
gneal@tamu.edu
About this study
Official title: The Texas Interprofessional Pharmacogenomics Registry and Repository
This program collects genetic and health information to help doctors choose the right medications for patients.
Read the detailed description
This study wants to understand how genes can affect how the body responds to medicines. This information will help us determine whether changing your medicine can make you healthier and improve your life. We will study your medical history for the last year and the next five years after you join the study.
study goals include:
- Enrolling patients who take multiple medications or have harmful side effects from their medications.
- Keeping all medical information and genetic samples from patients in one place.
- Helping doctors make better decisions about which medicines to prescribe.
- Influencing insurance companies and the government to help pay for this kind of medical care for people who need to change their medicine to stay healthy.
- Conditions
- Diabetes, Cholesterol, Cancer, Blood Pressure Disorders, Heart Disease, Respiratory Ilness
- Keywords
- REGISTRY, REPOSITORY, POLYPHARMACY, ADVERSE DRUG REACTION
- Medical subject headings
- Diabetes Mellitus, Neoplasms, Heart Diseases, Pulmonary Disease, Chronic Obstructive, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Polypharmacy | Patients taking many medications or medications with severe side effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and nature of ADRs on the Naranjo Scale
Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians. A physician or ambulatory pharmacist in the IPGx clinic or Family Care Clinic will obtain a complete medical history, physical examination, and validate the patient's current concomitant medication list at the IPGx during the office visit. Patient medical information would be input into the CSN, which functions as a computable EHR medical record analysis, evaluation of polypharmacy status, and monitoring of Adverse Drug Reactions using the Naranjo Scale questionnaire will be conducted for the duration of the study.
Measured: 5 years
Secondary outcomes (1)
Serum/plasma drug concentrations
Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians for an evaluation of pharmacokinetic and pharmacodynamic (PK/PD) assessments. For drug level measurement, urine samples will be collected using provided kits and shipped to the contracted laboratory via FedEx in biosafety shipping containers.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study startNov 2025 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726590
- Sponsor's protocol ID
- STUDY2023-0042
- Acronym
- IPGx Registry
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD deidentified
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Texas Interprofessional Pharmacogenomics Registry and Repository
- ClinicalTrials.gov ID
- NCT06726590
- Acronym / sponsor ID
- IPGx Registry / STUDY2023-0042
- Conditions
- Diabetes, Cholesterol, Cancer, Blood Pressure Disorders, Heart Disease, Respiratory Ilness
- Keywords
- REGISTRY, REPOSITORY, POLYPHARMACY, ADVERSE DRUG REACTION
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 10 Dec 2024 (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.
This program collects genetic and health information to help doctors choose the right medications for patients.
Detailed description
This study wants to understand how genes can affect how the body responds to medicines. This information will help us determine whether changing your medicine can make you healthier and improve your life. We will study your medical history for the last year and the next five years after you join the study.
study goals include:
- Enrolling patients who take multiple medications or have harmful side effects from their medications.
- Keeping all medical information and genetic samples from patients in one place.
- Helping doctors make better decisions about which medicines to prescribe.
- Influencing insurance companies and the government to help pay for this kind of medical care for people who need to change their medicine to stay healthy.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polypharmacy | – | –Patients taking many medications or medications with severe side effects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Texas A\&M Health clinical programs.
Key inclusion criteria (8 listed)
- The study will invite patients who are eligible for PGX workup/PGX care to participate, provided they meet the following criteria: Use of five or more medications, including over the counter drugs, supplements, natural products, cannabis products, or other recreational drugs, or
- Individuals taking blood pressure or depression medications, even if less than five medications.
- Ability to understand and give consent.
- Able to consent to donate blood and/or urine samples and buccal swabs.
- Able to answer detailed questionnaires, including quarterly questionnaires about ADRs, cognitive testing such as serial mini-mental status exams, and or quality of life questions.
Key exclusion criteria (5 listed)
- Individuals admitted to hospice.
- Declines to participate or interact with staff/share their medical status.
- A diagnosis of Alzheimer's disease or related dementias in a medical record as this indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning.,
- Individuals who are unable or unwilling to provide consent.
- Unable to verbally communicate and comprehend English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency and nature of ADRs on the Naranjo Scale
Time frame: 5 years
Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians. A physician or ambulatory pharmacist in the IPGx clinic or Family Care Clinic will obtain a complete medical history, physical examination, and validate the patient's current concomitant medication list at the IPGx during the office visit. Patient medical information would be input into the CSN, which functions as a computable EHR medical record analysis, evaluation of polypharmacy status, and monitoring of Adverse Drug Reactions using the Naranjo Scale questionnaire will be conducted for the duration of the study.
1 secondary outcome
Serum/plasma drug concentrations
Time frame: 5 years
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 12 Sep 2025.
- Individual participant dataSharing planned: Yes. All collected IPD deidentified
Related trials for Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
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.
Rick Silva, PhD contact
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 and Cholesterol, run by Texas A&M 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 8 inclusion and 5 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 12 Sep 2025. 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 Kenneth S Ramos, MD, PhD ((713) 677-7440, kramos@tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and nature of ADRs on the Naranjo Scale (time frame: 5 years). 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 12 Sep 2025.