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Clinical Trial Details

Trial ID: L1151
Source ID: NCT06555146
Associated Drug: Semaglutide, 0.5 Mg/Ml
Title: Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy
Acronym: Sema-RMA
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Kidney Disease, Chronic
Interventions: DRUG: Semaglutide, 0.5 mg/mL|DRUG: Placebo, Saline
Outcome Measures: Primary: Total blood flow, Volume of blood per unit time, ml/min, Measured 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 perfusion, volume of blood per unit time per unit tissue mass, ml/min/g, Measured 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) | Secondary: Glomerular filtration rate, Volume per unit time, ml/min, Measured with Tec99-DTPA clearance. 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)|Sodium excretion in urine, Concentration, mmol/l, One measurement will be done on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)|Activation of the renin angiotensin aldosterone system, Concentration, mmol/l, Blood samples will be taken 3 times on each intervention day, a total of 6 measurements for each participant, over the span of the study (approximately 1 year)|Blood pressure, mmhg, Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)|Heart Rate, Beats pr. minute, Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)
Sponsor/Collaborators: Sponsor: Bispebjerg Hospital
Gender: MALE
Age: ADULT
Phases:
Enrollment: 15
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2025-03
Results First Posted:
Last Update Posted: 2024-08-15
Locations: Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine, Copenhagen, Capital Region, 2400, Denmark
URL: https://clinicaltrials.gov/show/NCT06555146