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

Status

Recruiting

Phase

Phase not stated

Enrollment

250 participants (estimated)

Sponsor

Cardenal Herrera University · Other

Design

Not stated

Countries

1 country

Spain

Start

15 Sept 2023

Primary completion

31 Jul 2027 (estimated)

Completion

31 Dec 2028 (estimated)

First posted

30 Dec 2025

Last update posted

30 Dec 2025

Conditions

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

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.

• Other

  GLP-1RA Cohort

  Patients receiving GLP-1RA, mainly semaglutide: weekly administration, subcutaneous form, from 0.25mg (starting dose) to 1mg (maintenance dose) with monthly increase (0.25-0.5-1mg)

• Other

  SGLT2i Cohort

  There will also be another comparative group of patients under SGLT2i

• Other

  Other treatments

  Patients not under SGLT2i or GLP-1RA/Tirzepatide influence, but receiving other treatments that are part of CKD and diabetes standard care

• Other

  Dual GIP GLP-1RA

  Patients receiving tirzepatide: weekly administration, subcutaneous form, starting dose 2.5mg, maintenance 5mg

1. Ultrasonography change in perirenal adipose tissue thickness

   Time frame · 16 months

   Registry description

   Change in perirenal adipose tissue thickness as measured with ultrasonography

2. Change in estimated glomerular filtration rate

   Time frame · 16 months

   Registry description

   Change in eGFR as per the CKD-EPI formula