Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy
- Sponsor
- Bispebjerg Hospital
- Study ID
- NCT06555146
- Status
- Not Yet Recruiting
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Conditions
- Diabetes Mellitus, Type 2
- Kidney Disease, Chronic
Eligibility Criteria
- Sex
- MALE
- Age
- 20 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide, 0.5 mg/mL — DRUG1 subcutaneous injection on baseline day
- Placebo, Saline — DRUG1 subcutaneous injection on baseline day
Study Details
The goal of this double-blinded, placebo-controlled, randomized, crossover study is to examine the effect of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), on renal hemodynamics and function in patients with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD). The study will determine the effects of semaglutide on: * Renal arterial blood flow, regional renal perfusion, and oxygenation * Activity of the renin-angiotensin-aldosterone system (RAAS) * The glomerular filtration rate (GFR) * Sodium excretion in urine * Blood pressure and heart rate
Key Dates
- Start date
- Aug 31, 2024
- Status verified
- Aug 2024
- Primary completion
- Mar 31, 2025
- Completion
- Mar 31, 2025
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Other: Randomized to start with Semaglutide intervention in study period 1Placebo will be given in study period 2
- Other: Randomized to start with Placebo intervention in study period 1Semaglutide will be given in study period 2
Primary Outcome Measure
Total blood flow [ Time Frame: 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). ]
Central Contacts
- Peter Sørensen, MD+4530516279
- Ali Asmar, MD, PhD
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