Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07309094

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 90 Years

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

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 and study arms

GLP-1 receptor agonist

Drug

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

SGLT2 inhibitor

Drug

dapagliflozin: oral administration from 5 to 10mg/day

Tirzepatide

Drug

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

Other drugs

Drug

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...

Primary outcomes

Ultrasonography change in perirenal adipose tissue thickness16 months

Change in perirenal adipose tissue thickness as measured with ultrasonography

Change in estimated glomerular filtration rate16 months

Change in eGFR as per the CKD-EPI formula

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Vithas Valencia Consuelo🇪🇸 Valencia, Valencia, Spain

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Luis D'Marco, MD, PhDContact

Email · Call +34 96 317 78 00

Luis D'Marco, MD, PhDPrincipal Investigator