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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Patients will be asked to provide a blood, saliva and stool sample, answer questionnaires, complete online cognitive assessments ("brain games"), and wear a study-provided Fitbit device."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects samples and health data to find signs linked to long-term kidney disease and its worsening in people with type 2 diabetes. It is for South Carolina Medicaid members ages 40 to 70 with type 2 diabetes and a smaller group without diabetes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40 to 70 years old when you join.
  • Be enrolled in Medicaid.
  • Be able to agree to join and allow researchers to use needed health records and personal data.
  • Be able to give up to 70 mL of blood and other required samples, including genetic samples.
  • Diabetes group: Have type 2 diabetes or an A1c of 6.5% or higher in the past 12 months. A1c measures average blood sugar.
  • Comparison group: Have no type 2 diabetes diagnosis and an A1c of 5.6% or lower when you join.

Who can't join

  • Be pregnant when you join, based on your report.
  • Not be fluent in spoken and written English.
  • Have type 1 diabetes or any type of diabetes other than type 2.
  • Have active cancer, or cancer that fully cleared within the past 3 years. This does not include non-melanoma skin cancer.
  • Have had a major heart or blood vessel event within the past 2 years.
  • Have chronic obstructive pulmonary disease (COPD), a long-term lung disease, or a disease of the pancreas other than diabetes.
  • Have problems with memory or thinking, or a disease such as Alzheimer's, dementia, multiple sclerosis, or Parkinson's.
  • The study doctor thinks you are unlikely to finish all study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (2)

SC