Visceral Adipose Tissue and Liver Changes Associated With Semaglutide in CKD

NCT07187830 | Not Yet Recruiting

• 1 other identifier: U1111-1328-1600
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease in Type 2 Diabetes; Obesity & Overweight

Keywords

chronic kidney disease; cardiovascular disease; obesity; diabetes mellitus; steatosis

Outcome Measures

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.

  From enrollment to the end of follow-up at 12 months

Secondary Outcomes (1)

• Adiposopathy biomarkers in different CKD stages

  From enrollment to the end of follow-up at 12 months

Study Arms (2)

No semaglutide

Patients with diabetes not treated with semaglutide

Semaglutide

Patients with diabetes receiving semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Novo Nordisk Canada Inc.: collaborator

Study Sites (1)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood and serum samples

MeSH Terms

Conditions

Obesity; Overweight; Renal Insufficiency, Chronic; Cardiovascular Diseases; Diabetes Mellitus; Fatty Liver

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Paolo Raggi, M.D

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Luis G D'Marco, M.D; Ph,D.

  CEU Cardenal Herrera University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

CA (1)