NCT07731399

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Jul 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Oct 2029

Study Start

First participant enrolled

July 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

3.1 years

First QC Date

July 16, 2026

Last Update Submit

July 28, 2026

Conditions

Type 2 DiabetesHealthy (Controls)

Outcome Measures

Primary Outcomes (1)

  • 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

    Perform omics and clinical labs on blood and stool, administer surveys, and analyze medical record data

    Up to 24 months after enrollment

Study Arms (2)

Type 2 Diabetes

SC Medicaid-enrolled Type 2 Diabetes Patients

Other: Not applicable- observational study

Healthy Controls

SC Medicaid-enrolled non-T2D Patients

Other: Not applicable- observational study

Interventions

Not applicable- observational studyOTHER

Non-interventional biospecimen and data collection study.

Healthy ControlsType 2 Diabetes

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

South Carolina Medicaid-enrolled participants

You may qualify if:

  • All Participants:
  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clemson Health Clinic at Orangeburg

Orangeburg, South Carolina, 29118, United States

RECRUITING

Clemson Health Clinic at Walhalla

Walhalla, South Carolina, 29691, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Randy Axelrod, MD

    Guardian Research Network, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 28, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)