RightFit
RecruitingPhase not listed

Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Eligible subjects will return for a study visit within 4 weeks for a blood draw."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with type 1 diabetes, with or without long-term kidney disease. It looks at whether time spent in the target blood sugar range affects how high blood sugar must rise to activate certain immune cells and harm kidney filter cells. It also tests whether a GLP-1 drug reduces immune cell activity in samples outside the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–65 years old and have type 1 diabetes.
  • Use insulin shots or an insulin pump.
  • Use a continuous glucose monitor (CGM), a device that tracks blood sugar.
  • For the kidney disease group: have long-term kidney disease, with an eGFR kidney filtering score of 60–90.
  • For the kidney disease group: have protein in the urine, with a urine albumin-to-creatinine ratio (UACR) of 30–500 mg/g.
  • For the comparison group: have no kidney disease, an eGFR above 90, and a UACR below 30 mg/g.
  • For either group, have blood sugar in the target range less than 60% of the time with an A1c of 7.5–9.5, or more than 70% of the time with an A1c of 5.0–7.0. A1c measures average blood sugar over about 3 months.

Who can't join

  • Have hemoglobin below 9. Hemoglobin is the protein in blood that carries oxygen.
  • Use a GLP-1 agonist, DPP-4 inhibitor, or SGLT2 inhibitor, types of diabetes drugs, now or within the past 30 days.
  • Are pregnant or plan to become pregnant.
  • Take steroids.
  • Have cancer, a weakened immune system, or an autoimmune condition, where the immune system attacks the body.
  • Report heavy alcohol use or recreational drug use.
  • Have any condition that the doctor believes could make the study unsafe or affect monocytes, a type of immune cell.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

OH