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

NCT07731399

RecruitingN/A

Sponsor: Guardian Research Network, Inc.

Conditions: Type 2 Diabetes, Healthy (Controls)

Interventions: Not applicable- observational study

Countries: United States

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 overview

Sex: ALL

Age: 40 Years to 70 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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

Locations (2)

Orangeburg, South Carolina, United States
Walhalla, South Carolina, United States