Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

NCT06694558 | Recruiting

• 2 other identifiers: 24-1015K12DK133995
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with proinflammatory monocytes by flow cytometry, higher ER stress, and cytokine levels after monocyte exposure to hyperglycemia compared to euglycemia for 6 hours.

  Number of subjects with proinflammatory monocytes by flow cytometry, higher ER stress, and cytokine levels after monocyte exposure to hyperglycemia compared to euglycemia for 6 hours

  monocyte response to varying glycemic exposure after 6 hrs

Secondary Outcomes (1)

• Number of subjects with monocytes which induces higher podocyte injury after monocyte exposure to hyperglycemia compared to euglycemia for 6 hours.

  monocyte response to varying glycemic exposure after 6 hrs

Study Arms (1)

Patients with Type 1 Diabetes

Patients with Type 1 Diabetes with or without chronic kidney disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Type 1 Diabetes with or without chronic kidney disease.

You may qualify if:

• T1D CKD subjects:
• Adults, males or females diagnosed with T1D
• Age 18-65 years
• Diagnosed with CKD (eGFR 60-90 ml/min/1.73 m2)
• Diagnosed with albuminuria (UACR 30-500 mg/g)
• On insulin injections or pump
• 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
• Controls: T1D subjects without CKD
• Adults, males or females diagnosed with T1D
• Age 18-65 years
• No CKD (eGFR \>90 ml/min/1.73 m2)
• No albuminuria (UACR \<30 mg/g)
• On insulin injections or pump
• On CGM

You may not qualify if:

• Hemoglobin \<9
• On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days
• pregnancy or plans to become pregnant
• On steroids
• Diagnosed with cancer, immunosuppression/autoimmune conditions
• Reported heavy alcohol use or recreational drug use
• Any condition which jeopardizes patient safety or affects monocytes at physician's discretion

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Stanford University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rong M Zhang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Debs

CONTACT

216-445-8354; debsa@ccf.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 19, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)