Visceral Adipose Tissue and Liver Changes Associated With Semaglutide in CKD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
Obesity is considered a global pandemic and is associated with various diseases and metabolic complications, such as type 2 diabetes mellitus, high blood pressure, cholesterol disorders, cancer, cardiovascular disease, and kidney disease. Obesity can affect the kidneys in two main ways: indirectly, through mechanisms related to diabetes mellitus and/or high blood pressure, and directly, through complex proteins called "adipokines," which are produced by adipocytes.
Many of these adipokines are secreted by adipocytes under normal conditions, as they contribute to maintaining immune defenses and energy production. However, in obesity these adipokines acquire harmful properties and produce chronic inflammation in vital organs, such as the heart, blood vessels, the pancreas, and the kidney, leading to a deterioration in liver and kidney function.
New drugs such as glucagon-like peptide-1 receptor agonists (GLP-1Ras / Semaglutide), are not only effective to regulate blood sugar levels, but they produce weight loss improving kidney and liver function. However, little is known about their specific effect on the adipose tissue. Therefore, studies focusing on how these drugs work in fat could help us understand how diseased adipose tissue can affect patients with heart, liver, and kidney disease.
Investigators are asking patients who attend the diabetes clinics associated with the University of Alberta to join the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years of age.
Patients diagnosed with T2DM (>18 months) and CKD in stages G1, G2, G3a, G3b and G4; the CKD staging will be established according to the eGFR as per the KDIGO guidelines (G1: eGFR ≥90 ml/min/1.73m2; G2: 60-89 ml/min/1.73m2; G3a: 45-59 ml/min/1.73m2; G3b: 30-44 ml/ min/1.73m2; G4: 15-29 ml/ min/1.73m2).
Patients with T2DM and CKD, with or without semaglutide treatment.
Patients who voluntarily agree to participate and sign informed consent.
Disqualifiers
Patients <18 years of age.
Pregnant, breastfeeding, or an intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any)
Patients diagnosed with T2DM and CKD in stage G5 or stage G4 requiring dialysis as per KDIGO guidelines.
Previous participation in this trial (screened or randomized)
Trial population
Investigators will enroll patients with diabetic kidney disease at different stages of CKD receiving the GLP-1RA Semaglutide or SoC regimen, depending on their medical indication and cardiometabolic and hepatic steatosis stage.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
52 Participants
are grouped into 2 trial groupsGroup A: No semaglutide
Group B: Semaglutide
Trial outcomes
Primary outcomes
1
Correlation between kidney disease progression and cardiometabolic changes
To establish a correlation between kidney disease progression and cardiometabolic changes, focusing on region-specific adipose tissues such as perirenal, epicardial, and hepatic steatosis in patients with or without semaglutide treatment.
Time frame
From enrollment to the end of follow-up at 12 monthsSecondary outcomes
1
Adiposopathy biomarkers in different CKD stages
Adiposopathy biomarker comparisons between different CKD severity stages will be investigated
Time frame
From enrollment to the end of follow-up at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Novo Nordisk A/S
Collaborator
Source ClinicalTrials.gov