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| Name | Class |
|---|---|
| Novo Nordisk Canada Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No semaglutide | Patients with diabetes not treated with semaglutide | ||
| Semaglutide | Patients with diabetes receiving semaglutide |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adiposopathy biomarkers in different CKD stages | Adiposopathy biomarker comparisons between different CKD severity stages will be investigated | From enrollment to the end of follow-up at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Raggi, M.D | University of Alberta | Principal Investigator |
| Luis G D'Marco, M.D; Ph,D. | CEU Cardenal Herrera University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazankowski Alberta Heart Institute | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2025 | Sep 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 28, 2025 | Sep 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Urine, blood and serum samples
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |