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Recruiting Observational

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

NCT07309094 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2023-09-15
Last updated
2025-12-30

Condition(s) studied

Chronic Kidney Disease stage3Chronic Kidney Disease stage4Chronic Kidney Disease Stage 1Chronic Kidney Disease Stage 2ObesityDiabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

GLP-1 receptor agonist →SGLT2 inhibitor →Tirzepatide →Other drugs →

GLP-1 receptor agonist: Semaglutide: weekly subcutaneous administration, starting dose 0.25mg, maintenance dose 1mg

SGLT2 inhibitor: dapagliflozin: oral administration from 5 to 10mg/day

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

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...

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * \> or = 18 years of age * diagnosed with CKD in stages G1, G2, G3a, G3b, and G4, not candidate for dialysis * had uncontrolled T2DM, CVDs and/or obesity * willing to participate in the study and sign informed consent Exclusion Criteria: * Age \<18 years * pregnancy * CKD in stage G5 or G4 candidate for dialysis * neuropsychiatric diseases preventing the patient from understanding the benefits/risks associated with the project * refusal to participate and/or consent revocation were considered as exclusion criteria

Primary outcome measure(s)

  • Ultrasonography change in perirenal adipose tissue thickness — 16 months
    Change in perirenal adipose tissue thickness as measured with ultrasonography
  • Change in estimated glomerular filtration rate — 16 months
    Change in eGFR as per the CKD-EPI formula

Trial sites (1)

FacilityCityRegionStatus
Vithas Valencia Consuelo Valencia Valencia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07309094 on ClinicalTrials.gov ↗ ← All trials in Spain