An interventional study of Semaglutide, 0.5 mg/mL and Placebo, Saline in Diabetes Mellitus, Type 2 and Kidney Disease, Chronic, sponsored by Bispebjerg Hospital. Not yet recruiting at 1 site in Denmark. Open to male participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Basic science
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:
Mechanistic studies conducted in healthy humans demonstrate a Glucagon-like peptide-1 (GLP-1)-mediated gut-kidney crosstalk. The expansion of extracellular fluid volume uncovers a natriuretic action of GLP-1. This feed-forward natriuretic system is associated with high renal extraction of GLP-1, suppression in circulating angiotensin II levels, and increased renal medullary and cortical perfusion and oxygenation. Besides potent glucose-lowering actions, Glucagon-like peptide-1 receptor agonists (GLP-1RAs) improve body weight, blood pressure, and dyslipidemia, and cardiovascular and renal outcome trials demonstrate beneficial actions of GLP-1RAs used in patients with type 2 diabetes mellitus (T2DM).
Thus the beneficial cardiovascular effects of GLP-1 may partly be related to renoprotection and might represent the restoration of the gut-kidney crosstalk.
The aim of the present study is to investigate possible mechanisms behind the renal effects of semaglutide in patients with type 2 diabetes mellitus and moderate chronic kidney disease.
This is a double-blinded, placebo-controlled, crossover study and patients will participate in two independent and randomized study periods with a washout period of around 4 weeks in between.
Fifteen male participants with type 2 diabetes mellitus in the age group 20-60 years are screened, randomized, and expected to complete the present study. Informed consent is obtained before the screening meeting followed by a 30-day run-in period prior to study days.
The two study periods each extend over 8 days, where all participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol + 2 mmol/kg sodium for 7 days. On the fourth day before each of the two baseline trials, 24-hour urine collection will be performed. Throughout the 7 days, water intake will be ad libitum and physical activity will not be allowed.
Each period consists of Baseline day (day 5) and Intervention day (day 8)
Renal flow, perfusion, and oxygenation are measured on both days, using multiparametric MRI.
Glomerular filtration rate (GFR) is measured, using Tc99m-Diethylenetriamine pentaacetic acid (DTPA) plasma clearance.
After conducting the baseline study, the participant is given a subcutaneous injection of either semaglutide or placebo.
During the intervention study, MRI is followed by catheterization of a renal vein via the femoral vein (the Seldinger technique) for blood sampling.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 15 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo will be given in study period 2
Drug: Semaglutide, 0.5 mg/mL · Drug: Placebo, Saline
Semaglutide will be given in study period 2
Drug: Semaglutide, 0.5 mg/mL · Drug: Placebo, Saline
1 subcutaneous injection on baseline day
1 subcutaneous injection on baseline day
Total blood flow
Volume of blood per unit time, ml/min
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).
Regional renal perfusion
volume of blood per unit time per unit tissue mass, ml/min/g
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)
Glomerular filtration rate
Volume per unit time, ml/min
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Bispebjerg Hospital