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Clinical trial Recruiting at 2 sites Observational Ages 40 to 70

Multiomic data study in South Carolina Medicaid patients with Type 2 diabetes and healthy controls

Official title: An Observational Clinical Research Study Assembling and Analyzing Highly Complex, Multi-dimensional Molecular and Clinical Data With a Focus on High-risk Diabetes Patients in South Carolina, in Support of the Biomedical Research Initiative for Scientific Knowledge (BRISK)

Run by Guardian Research Network, Inc. · NCT07731399 · Data updated 2026-11-12

This study tests whether combining genetic, molecular, clinical, wearable, and lifestyle data in SC Medicaid patients with Type 2 diabetes, and in healthy controls, can help predict kidney disease and diabetes progression.

Quick facts

Study typeObservational
Ages40 Years to 70 Years
SexAll
Enrollment1200 (estimated)
SponsorGuardian Research Network, Inc.
Academic / other
Locations2 sites (Orangeburg, South Carolina and 1 other locations)
StatusRecruiting
StartedAugust 2026
Main results expectedAugust 2029
Study endsOctober 2029
Registry record updatedAugust 18, 2026
Trial IDNCT07731399 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 40–70 enrolled in South Carolina Medicaid, with Type 2 diabetes or without diabetes, who can provide consent and blood samples.

Probably not a fit

Individuals who do not have or develop CKD risk signals within the study period or who do not engage with wearable devices may see limited direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects biospecimens, electronic health records, cognitive tests, questionnaires, wearable device data, and lifestyle information from SC Medicaid-enrolled adults with Type 2 diabetes and a healthy control group. Researchers aim to identify data elements or combinations that correlate with chronic kidney disease diagnosis or progression in Type 2 diabetes. The study will analyze how multiomic and clinical data relate to health trajectories to inform prevention and treatment strategies. Participants may receive compensation and keep a provided Fitbit; they will have access to a Certified Diabetes Educator for consultation.

Why it matters

Potential benefit: If successful, the study could improve prediction of kidney disease risk and diabetes progression, guiding personalized prevention and treatment strategies.

How similar studies have gone: Previous efforts using multiomic and clinical data have shown promise in identifying disease trajectories, though this study’s focus on Medicaid populations and CKD in T2D is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
INCLUSION CRITERIA:

All Participants:

* 40 to 70 years of age (inclusive) at enrollment
* Enrolled as Medicaid recipients
* Ability to provide informed consent and authorization for release of relevant protected health information or personal data
* Ability to provide a blood sample(s) of up to 70 mL and other required biospecimens, including genetic samples.

T2D Group:

• Current diagnosis of Type 2 diabetes OR a blood level of hemoglobin A1c equal to or greater than 6.5% at any time within the past 12 months

Control Group:

* Blood level of hemoglobin A1c less than or equal to 5.6% at time of enrollment
* No diagnosis of Type 2 diabetes

EXCLUSION CRITERIA:

* Pregnancy at time of enrollment (by self-report of pregnancy status)
* Lack of fluency in spoken and written English
* Type 1 diabetes or any other type of diabetes besides Type 2 diabetes
* Active cancer diagnosis or cancer that achieved complete remission within three (3) years prior to enrollment, other than non-melanoma skin cancer (e.g. malignant basal cell neoplasm of skin and/or squamous cell carcinoma of skin)
* Major Adverse Cardiovascular Events within two (2) years prior to enrollment
* Chronic Obstructive Pulmonary Disease
* Cognitive impairment or neurodegenerative diseases (e.g., Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, etc.)
* Pancreatitis or other diseases of the pancreas (besides diabetes)
* The participant is, in the opinion of the investigator, unlikely to be able to complete all study requirements

Where it's running

  • Clemson Health Clinic at Orangeburg
    Orangeburg, South Carolina, United States     Recruiting
  • Clemson Health Clinic at Walhalla
    Walhalla, South Carolina, United States     Recruiting

Study contacts

  • Principal investigator: Randy Axelrod, MD — Guardian Research Network, Inc.

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.