NCT07731399Recruiting
Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls
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)
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
The primary purpose of this study is to use multiomic data in combination with clinical assessments, electronic health records, cognitive and mood assessments, wearable technologies and lifestyle/behavioral data to identify data elements or combinations of data elements with strong positive or negative correlation to CKD diagnosis and/or progression in Type 2 Diabetes (T2D) patients. Achieving this aim will allow researchers and physicians to significantly improve the prediction of health trajectories of and formulate novel strategies to potentially prevent, treat or reverse T2D. South Carolina Medicaid-enrolled patients diagnosed with T2D and a smaller subset of non-T2D SC Medicaid patients may participate in this study. Participants who complete required procedures will be compensated for their time and transportation, may keep their study-provided Fitbit device to help maintain their healthcare improvement journey, and will have a personal Certified Diabetes Educator to consult and assist with managing their diabetes diagnosis.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 16 Jul 2026
- Start date
- Aug 2026
- Primary completion date
- Aug 2029
- Lead sponsor
- Guardian Research Network, Inc.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07731399
What you commit to
- Study type: Observational
- Planned participants: 1200
- From Aug 2026 to the primary completion date, Aug 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Type 1 diabetes or any other type of diabetes besides Type 2 diabetes
- 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)
Other
- Pregnancy at time of enrollment (by self-report of pregnancy status)
- Lack of fluency in spoken and written English
- The participant is, in the opinion of the investigator, unlikely to be able to complete all study requirements
Who the study is looking for
- 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
Age in the registry: 40 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clemson Health Clinic at Orangeburg Coordinator of this site? Confirm its status | Orangeburg | United States | Recruiting |
| Clemson Health Clinic at Walhalla Coordinator of this site? Confirm its status | Walhalla | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.