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Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1RA in CKD

NCT07309094 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-12-30

No results posted yet for this study

Summary

Chronic kidney disease (CKD) is the progressive damage to kidney function, associated with an increased risk of cardiovascular diseases, such as stroke or myocardial infarct, particularly in the most severe stages of CKD, in which the patient requires dialysis. Several risk factors are reported for CKD, such as diabetes mellitus, obesity and hypertension. One of the most increasingly recognized risk factors is the fat tissue malfunction, known as adiposopathy. The accumulation of fat tissue around the organs in conditions of obesity or diabetes accelerates the production of pro-inflammatory factors that may worsen the kidney and heart damage. New antidiabetic medications, such as glucagon-like peptide-1 receptor agonists (GLP-1RA), have proven beneficial effects on the kidney and heart due to several mechanisms, including anti-inflammatory actions and a potential action on the fat tissue.

The aim of this study is to assess the link between adiposopathy and CKD, by investigating the changes in adiposopathy measures throughout treatment with GLP-1RA to a sample of patients with CKD.

Conditions

  • Chronic Kidney Disease stage3
  • Chronic Kidney Disease stage4
  • Chronic Kidney Disease Stage 1
  • Chronic Kidney Disease Stage 2
  • Obesity
  • Diabetes Mellitus, Type 2

Interventions

DRUG

GLP-1 receptor agonist

Semaglutide: weekly subcutaneous administration, starting dose 0.25mg, maintenance dose 1mg

DRUG

SGLT2 inhibitor

dapagliflozin: oral administration from 5 to 10mg/day

DRUG

Tirzepatide

subcutaneous injection: starting dose 2.5 mg, maintenance 5mg (weekly administration)

DRUG

Other drugs

Patients not under SGLT2i or GLP-1RA influence, but receiving other treatments which are part of CKD standard care: mineralocorticoid receptor agonists, metformin, ACE inhibitors, ARBs...

Sponsors & Collaborators

  • Cardenal Herrera University

    lead OTHER

Principal Investigators

  • Luis D'Marco, MD, PhD · Cardenal Herrera University

  • Ana Checa-Ros, MD, PhD · Cardenal Herrera University

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2027-07-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309094 on ClinicalTrials.gov