RecruitingNCT07309094

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

Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1 Receptor Agonists in Chronic Kidney Disease


Sponsor

Cardenal Herrera University

Enrollment

250 participants

Start Date

Sep 15, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • \> 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 Criteria4

  • 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

Interventions

DRUGGLP-1 receptor agonist

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

DRUGSGLT2 inhibitor

dapagliflozin: oral administration from 5 to 10mg/day

DRUGTirzepatide

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

DRUGOther 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...


Locations(1)

Vithas Valencia Consuelo

Valencia, Valencia, Spain

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NCT07309094


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