Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls | NCT07731399

NCT07731399

Overview

NCT ID: NCT07731399
Lead Sponsor: Guardian Research Network, Inc.OTHER
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)
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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Aug 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 1,200Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Clemson Health Clinic at Orangeburg

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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