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NCT Number: NCT06694558

Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

  • 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

Treatment and study plan

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.

    Time frame: monocyte response to varying glycemic exposure after 6 hrs

    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

Secondary outcomes

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

    Time frame: monocyte response to varying glycemic exposure after 6 hrs

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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Debs

CONTACT

[email protected]

216-445-8354

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Stanford University

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 19, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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