Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

ConditionsChronic Kidney Disease(CKD)Type 1 Diabetes (T1D)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

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

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants

are grouped into 1 trial group

Group A: Patients with Type 1 Diabetes

Trial outcomes

Primary outcomes

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

Time frame

monocyte response to varying glycemic exposure after 6 hrs

Secondary outcomes

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

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

Time frame

monocyte response to varying glycemic exposure after 6 hrs

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Stanford University

Collaborator

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