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NCT Number: NCT07187830

Visceral Adipose Tissue and Liver Changes Associated With Semaglutide in CKD

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.

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Key information

Conditions

Chronic Kidney Disease in Type 2 Diabetes Body Weight Cardiovascular Diseases Chronic Disease Diabetes Mellitus Digestive System Diseases Disease Attributes Endocrine System Diseases Fatty Liver Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Liver Diseases Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

Maryam Rezaeifar, M.D

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation between kidney disease progression and cardiometabolic changes

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

    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.

Secondary outcomes

  1. Adiposopathy biomarkers in different CKD stages

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

    Adiposopathy biomarker comparisons between different CKD severity stages will be investigated

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Novo Nordisk Canada Inc.

Registry information

Official study title

Region-specific Adipose Tissues and Liver Changes Associated With Semaglutide Treatment in Chronic Kidney Disease Patients

Acronym: ADIPOLIVE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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