Chronic Kidney Disease in Type 2 DiabetesADIPOLIVENCT07187830
Visceral Adipose Tissue and Liver Changes Associated With Semaglutide in CKD
An observational study of Chronic Kidney Disease in Type 2 Diabetes and Obesity & Overweight, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease in Type 2 Diabetes, Obesity & Overweight
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2026to 15 Jan 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7
Ali Syed, 5873722453, alisyed1@ualberta.ca
Luis G D'Marco, M.D; Ph.D., dmarcoga@ualberta.ca
About this study
Official title: Region-specific Adipose Tissues and Liver Changes Associated With Semaglutide Treatment in Chronic Kidney Disease Patients
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.
Read more
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.
Read the 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.
- Keywords
- chronic kidney disease, cardiovascular disease, obesity, diabetes mellitus, steatosis
- Medical subject headings
- Obesity, Overweight, Renal Insufficiency, Chronic, Cardiovascular Diseases, Diabetes Mellitus, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No semaglutide | Patients with diabetes not treated with semaglutide | |
| Semaglutide | Patients with diabetes receiving semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of follow-up at 12 months
Secondary outcomes (1)
Adiposopathy biomarkers in different CKD stages
Adiposopathy biomarker comparisons between different CKD severity stages will be investigated
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start23 Feb 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease in Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Paolo Raggi, M.D, Principal investigator, University of AlbertaLuis G D'Marco, M.D; Ph,D., Principal investigator, CEU Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187830
- Sponsor's protocol ID
- U1111-1328-1600
- Acronym
- ADIPOLIVE
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Region-specific Adipose Tissues and Liver Changes Associated With Semaglutide Treatment in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT07187830
- Acronym / sponsor ID
- ADIPOLIVE / U1111-1328-1600
- Keywords
- chronic kidney disease, cardiovascular disease, obesity, diabetes mellitus, steatosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No semaglutide | – | –Patients with diabetes not treated with semaglutide |
| Semaglutide | – | –Patients with diabetes receiving semaglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Adiposopathy biomarkers in different CKD stages
Time frame: From enrollment to the end of follow-up at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Raggi, M.D principal investigator
University of Alberta
Luis G D'Marco, M.D; Ph,D. principal investigator
CEU Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease in Type 2 Diabetes and Obesity & Overweight, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between kidney disease progression and cardiometabolic changes (time frame: From enrollment to the end of follow-up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.