Visceral Adipose Tissue and Liver Changes Associated With Semaglutide in CKD
Recruiting · NCT07187830 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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)
- Patients diagnosed with neuropsychiatric diseases that prevent them from understanding the benefits/risks associated with the project or voluntarily choosing to participate.
- Known or suspected allergy to trial medication(s), excipients, or related products
- Contraindications to study medication(s), worded specifically as stated in the Product Monograph
- Refusal to participate or consent revocation.
Where it is running
2 locations listed.
- Mazankowski Alberta Heart Institute - Edmonton, Alberta, Canada
- Mazankowski Alberta Heart Institute - Edmonton, Alberta, Canada