Recruiting

Observational Study

Sponsor:

Guardian Research Network, Inc.

Code:

NCT07731399

Conditions

Type 2 Diabetes

Healthy (Controls)

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

Not applicable- observational study

Study Details

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.

Conditions

Type 2 Diabetes

Healthy (Controls)

Study ID

NCT07731399

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

Type 2 Diabetes

SC Medicaid-enrolled Type 2 Diabetes Patients

Healthy Controls

SC Medicaid-enrolled non-T2D Patients

Interventions

Not applicable- observational study

Non-interventional biospecimen and data collection study.

Primary outcome measure

  • Identify data elements or combinations of data elements with strong positive or negative correlation to Chronic Kidney Disease diagnosis and/or progression in Type 2 Diabetes patients [ Time Frame: Up to 24 months after enrollment ]

Central Contacts and Locations

Locations

Clemson Health Clinic at Orangeburg

Recruiting

Orangeburg, South Carolina, United States, 29118

Contacts

Katie Poplin

864-656-4503kpoplin@clemson.edu

Jeremy Shields

864-656-4503jnshiel@clemson.edu

Principal Investigator:

Peter Carek, MD

Clemson Health Clinic at Walhalla

Recruiting

Walhalla, South Carolina, United States, 29691

Contacts

Katie Poplin

864-656-4503kpoplin@clemson.edu

Jeremy Shields

864-656-4503jnshiel@clemson.edu

Principal Investigator:

Peter Carek, MD

More Information

Sponsor

Guardian Research Network, Inc.

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Guardian Research Network, Inc. on 2026-08-18.