Chronic Kidney Disease(CKD)NCT06694558
Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease
An observational study of Chronic Kidney Disease(CKD) and Type 1 Diabetes (T1D), run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease(CKD), Type 1 Diabetes (T1D)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type 1 Diabetes with or without chronic kidney disease.
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Andrea Debs, 216-445-8354, debsa@ccf.org
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease(CKD), Type 1 Diabetes (T1D)
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 1 Diabetes | Patients with Type 1 Diabetes with or without chronic kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Number of subjects with monocytes which induces higher podocyte injury after monocyte exposure to hyperglycemia compared to euglycemia for 6
Measured: monocyte response to varying glycemic exposure after 6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Mar 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Rong M Zhang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694558
- Sponsor's protocol ID
- 24-1015
- Other IDs
- K12DK133995
- Status last verified
- Jul 2026
- First submitted
- 5 Nov 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06694558
- Acronym / sponsor ID
- 24-1015
- Conditions
- Chronic Kidney Disease(CKD), Type 1 Diabetes (T1D)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Stanford University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 1 Diabetes | – | –Patients with Type 1 Diabetes with or without chronic kidney disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 1 Diabetes with or without chronic kidney disease.
Key inclusion criteria (16 listed)
- T1D CKD subjects:
- 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
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong M Zhang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease(CKD) and Type 1 Diabetes (T1D), run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Debs (216-445-8354, debsa@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.