Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

NCT ID: NCT06694558

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-07-01

Brief Summary

This is a cross-sectional study in patients with Type 1 diabetes (TID) and chronic kidney disease (CKD) to test if time in range (TIR) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (GLP-1) agonist treatment ex vivo.

Detailed Description

The monocyte response from patients with T1D CKD will be compared to monocytes from T1D subjects without CKD as a control. Potential subjects will be recruited from existing Cleveland Clinic patients or the community. The study will entail an initial phone screen followed by a formal screening visit to determine eligibility. Eligible subjects will return for a study visit within 4 weeks for a blood draw. There is no intervention. This will complete the study for subjects unless the investigators do not obtain enough monocytes from the initial blood draw to complete the requisite lab studies. If this occurs, the investigators will ask the patient to return for a repeat study visit. All endpoints evaluating monocyte and podocyte injury will be conducted in the lab ex vivo.

Conditions

Chronic Kidney Disease(CKD); Type 1 Diabetes (T1D)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with Type 1 Diabetes

Patients with Type 1 Diabetes with or without chronic kidney disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. T1D CKD subjects:

1. Adults, males or females diagnosed with T1D

2. Age 18-65 years

3. Diagnosed with CKD (eGFR 60-90 ml/min/1.73 m2)

4. Diagnosed with albuminuria (UACR 30-500 mg/g)

5. On insulin injections or pump

6. On CGM

Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR<60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR>70% A1c 5.0-7.0

2. Controls: T1D subjects without CKD

1. Adults, males or females diagnosed with T1D

2. Age 18-65 years

3. No CKD (eGFR >90 ml/min/1.73 m2)

4. No albuminuria (UACR <30 mg/g)

5. On insulin injections or pump

6. On CGM

Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR<60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR>70% A1c 5.0-7.0

Exclusion Criteria

1. Hemoglobin <9

2. On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days

3. pregnancy or plans to become pregnant

4. On steroids

5. Diagnosed with cancer, immunosuppression/autoimmune conditions

6. Reported heavy alcohol use or recreational drug use

7. Any condition which jeopardizes patient safety or affects monocytes at physician's discretion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rong M Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrea Debs

Role: CONTACT

debsa@ccf.org

216-445-8354

Facility Contacts

Andrea Debs

Role: primary

debsa@ccf.org

216-445-8354

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K12DK133995

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1015

Identifier Type: -

Identifier Source: org_study_id