Recruiting

GLP-1 Agonist

Sponsor:

The Cleveland Clinic

Code:

NCT06694558

Conditions

Chronic Kidney Disease(CKD)

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT06694558

Start date

Mar 1, 2025

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Type 1 Diabetes

Patients with Type 1 Diabetes with or without chronic kidney disease

Primary outcome measure

  • 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. [ Time Frame: monocyte response to varying glycemic exposure after 6 hrs ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-07-08.