Visceral Adipose Tissue and Liver Changes Associated With Semaglutide in CKD

NCT ID: NCT07187830

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2028-01-15

Brief Summary

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.

Detailed Description

If participants agree to join the study, they will be asked to undergo a magnetic resonance imaging (MRI) scan to measure the fat around the heart, liver, and kidneys. During the abdominal MRI scan, the fat content of the liver will also be measured.

When participants arrive for the imaging test, they will first sign an informed consent form. Participants will then proceed to have their MRI imaging test.

The MRI imaging study will be performed in the MRI Research Center on the lower level of the Mazankowski Alberta Heart Institute (part of the University Hospital). Study personnel will also ask participants questions about their medical history. Other information collected will include medications, recent tests the participants' doctor may have ordered, and basic information such as age, sex, weight, and height.

Conditions

Chronic Kidney Disease in Type 2 Diabetes; Obesity & Overweight

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

No semaglutide

Patients with diabetes not treated with semaglutide

No interventions assigned to this group

Semaglutide

Patients with diabetes receiving semaglutide

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk Canada Inc.

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Raggi, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Luis G D'Marco, M.D; Ph,D.

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

Countries

Canada

Facility Contacts

Maryam Rezaeifar, M.D

Role: primary

rezaeif1@ualberta.ca

Luis G D'Marco, M.D; Ph.D.

Role: backup

dmarcoga@ualberta.ca

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U1111-1328-1600

Identifier Type: -

Identifier Source: org_study_id