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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - \> 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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...

Locations (1)

Vithas Valencia Consuelo
Valencia, Valencia, Spain