Actively Recruiting

Age: 18Years - 90Years
All Genders
ID07309094

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

Led by Cardenal Herrera University · Updated on 2025-12-30

250

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the relationship between adiposopathy, a malfunction of fat tissue, and chronic kidney disease (CKD), a condition where kidney function progressively worsens. This study focuses on patients with CKD stages 1 to 4 who also have type 2 diabetes, cardiovascular diseases, or obesity. The study aims to understand how treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), such as semaglutide and tirzepatide, affects adiposopathy and related kidney and heart risks. CKD progression is linked to increased cardiovascular risk, especially in severe stages requiring dialysis, and adiposopathy may worsen this risk through inflammation. Participants will be in one of several groups receiving different treatments: weekly subcutaneous injections of GLP-1RA (semaglutide or tirzepatide) with dose escalation, daily oral SGLT2 inhibitors, or other standard CKD care medications not involving GLP-1RA or SGLT2 inhibitors. The treatment phase lasts 16 months, during which changes in adipose tissue thickness around organs and kidney function will be monitored using ultrasound and blood tests. Throughout the 16 months, participants will undergo evaluations including ultrasound measurements of various fat tissue areas, blood tests for markers like leptin and adiponectin, and urine tests for kidney injury indicators. Researchers will track changes in fat tissue distribution and kidney function to assess treatment effects. Participants will provide informed consent and be monitored periodically to measure the study outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Diagnosed with chronic kidney disease in stages G1, G2, G3a, G3b, or G4 and not a candidate for dialysis
  • Have uncontrolled type 2 diabetes, cardiovascular diseases, and/or obesity
  • Willing to participate in the study and sign informed consent
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant
  • Chronic kidney disease in stage G5 or stage G4 candidate for dialysis
  • Neuropsychiatric diseases that prevent understanding the study benefits and risks
  • Refusal to participate or withdrawal of consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 16 months

Participants who undergo routine care with GLP-1 receptor agonists, SGLT2 inhibitors, tirzepatide, or other standard treatments for chronic kidney disease and diabetes are observed to assess clinical, morphometric, and biochemical changes related to adiposopathy.

Regular visits to monitor changes over 16 months

Trial Site Locations

Total: 1 location

1

Vithas Valencia Consuelo

Valencia, Valencia, Spain, 46007

Actively Recruiting

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Research Team

A

Ana Checa-Ros, MD, PhD

L

Luis D'Marco, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Published Research Related To This Trial

Regulation of Na+/H+ exchanger NHE3 by glucagon-like peptide 1 receptor agonist exendin-4 in renal proximal tubule cells.

Luciene R Carraro-Lacroix, Gerhard Malnic, Adriana C C Girardi

https://pubmed.ncbi.nlm.nih.gov/19776173

GLP-1 receptor agonists for prevention of cardiorenal outcomes in type 2 diabetes: An updated meta-analysis including the REWIND and PIONEER 6 trials.

Dario Giugliano, Maria Ida Maiorino, Giuseppe Bellastella...

https://pubmed.ncbi.nlm.nih.gov/31373167

Contemporary Trends and Outcomes in Patients With ST-Segment Elevation Myocardial Infarction and End-Stage Renal Disease on Dialysis: Insight from the National Inpatient Sample.

Muhammad Zia Khan, Moinuddin Syed, Mohammed Osman...

https://pubmed.ncbi.nlm.nih.gov/32444271

Framing Cause-Effect Relationship of Acute Coronary Syndrome in Patients with Chronic Kidney Disease.

Mădălina Ioana Moisi, Simona Gabriela Bungau, Cosmin Mihai Vesa...

https://pubmed.ncbi.nlm.nih.gov/34441451