NCT07731399 Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls
| NCT ID | NCT07731399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guardian Research Network, Inc. |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2026-08 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2026-08 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Randy Axelrod, MD
PRINCIPAL INVESTIGATOR
Guardian Research Network, Inc.
Frequently Asked Questions
Who can join the NCT07731399 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07731399 currently recruiting?
Yes, NCT07731399 is actively recruiting participants. Visit ClinicalTrials.gov or contact Guardian Research Network, Inc. to inquire about joining.
Where is the NCT07731399 trial being conducted?
This trial is being conducted at Orangeburg, United States, Walhalla, United States.
Who is sponsoring the NCT07731399 clinical trial?
NCT07731399 is sponsored by Guardian Research Network, Inc.. The principal investigator is Randy Axelrod, MD at Guardian Research Network, Inc.. The trial plans to enroll 1,200 participants.
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