Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy
- Status
- UnknownResults none
- Why it is watched
- non-weight indication: kidney
- Who it enrolls
- age 20 Years to 60 Years; male; no BMI minimum stated; conditions: Diabetes Mellitus, Type 2; Kidney Disease, Chronic
- Interventions
- Semaglutide, 0.5 mg/mL; Placebo, Saline
- Conditions
- Diabetes Mellitus, Type 2; Kidney Disease, Chronic
- Phase and size
- NA · 15 participants
- Dates
- Start 2024-08
Primary completion 2025-03 - Sponsor
- Bispebjerg Hospital (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Total blood flowMeasured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year).
- Regional renal perfusionMeasured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)
02Eligibility
Who can take part
Inclusion Criteria: * Type 2 diabetes mellitus diagnosed through either HbA1c ≥6,5% but ≤8,5%, or \<6,5% combined with either fasting plasma glucose ≥7,0 mmol/L or plasma glucose ≥11,1 mmol/L two hours after an oral glucose tolerance test (OGTT). * Estimated glomerular filtration rate (eGFR, CKD-EPI) between 30-60 mL/min/1.73m2 * Urine Albumin:Creatinine ratio (UACR) ≥30mg/g * Stable RAAS blockade (ACE inhibitors or angiotensin II receptor blocker (ARB) with stable dosis for 4 weeks prior to screening) * Discontinuation of treatment with selective sodium glucose transporter inhibitors (SGLT2i), dipeptidyl peptidase 4 inhibitors (DPP-4i), GLP-1R analogs, rapid-acting and mix insulin 30 days before screening. Exclusion Criteria: * Immunosuppressive therapy within 30 days of screening * Alcohol abuse * Medical treatment with glucocorticoids * Kidney transplantation * Treatment for renal failure with dialysis * Myocardial infarction within 3 months of screening * Heart failure (NYHA 3-4) * Dysregulated arterial hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥ 100 mm Hg) * Liver disease (ALAT \>2 x normal value) * Conditions which may interfere with the glucose metabolism according to the PI * Severe claustrophobia * Elements incompatible with MRI * Abnormal kidney size and/or position * Venous and arterial anatomy hindering catheterization.
03Change log
Registry changes
No changes recorded since the trial was added.