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

Sponsor
Cardenal Herrera University
Study ID
NCT07309094
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 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...

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: 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)
  • Arm: SGLT2i Cohort
    There will also be another comparative group of patients under SGLT2i
  • Arm: Other treatments
    Patients not under SGLT2i or GLP-1RA/Tirzepatide influence, but receiving other treatments that are part of CKD and diabetes standard care
  • Arm: Dual GIP GLP-1RA
    Patients receiving tirzepatide: weekly administration, subcutaneous form, starting dose 2.5mg, maintenance 5mg

Primary Outcome Measure

Ultrasonography change in perirenal adipose tissue thickness [ Time Frame: 16 months ]

Central Contacts

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