An interventional study of Glucagon and Placebo in Kidney Diseases, sponsored by Ali Asmar. Recruiting at 1 site in Denmark. Open to male participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Ali Asmar · Not applicable, Interventional, and Basic science
The goal of this crossover study is to investigate to what extend glucagon affects the kidneys. The main questions it aims to answer are:
Does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration? Does glucagon regulate kidney function by increasing renal plasma flow and glomerular filtration rate? Does glucagon regulate kidney function by increasing renal salt excretion?
In patients with type 2 diabetes mellitus, plasma concentrations of glucagon are inappropriately high (hyperglucagonemia). Hyperglucagonemia has been speculated to contribute to the pathophysiology of diabetic kidney disease. Previously, glucagon has been assumed to cause glomerular hyperfiltration associated with urinary excretion of small proteins, a characteristic of early type 2 diabetic kidney injury. Further, glucagon has been shown to acutely increase urinary excretion of urea, sodium, and potassium, and patients with end-stage renal disease have elevated plasma levels of glucagon.
The purpose of this study is to clarify the underlying mechanisms behind the physiological effects of glucagon on kidney function and the kidney's ability to clear glucagon from the blood in healthy males. Specifically, the investigators aim to answer the following questions:
Does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration? Does glucagon regulate kidney function by increasing renal plasma flow and glomerular filtration rate? Does glucagon regulate kidney function by increasing renal salt excretion?
The renal extraction of glucagon and the renal effects of glucagon will be investigated during a constant glucagon infusion in 10 healthy men aged 20-60 years. The study will be placebo-controlled. Each subject will participate in three independent and randomized trial days with a washout period of at least four weeks.
3,838 studies on the registry are indexed under Kidney Diseases; 498 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 2,639 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →This is the only study on the registry with Ali Asmar as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Glucagon infusion of 5 ng·kg-1·min-1 from 0-60 minutes and 10 ng·kg-1 ·min-1 from 60-120 minutes.
Other: Glucagon · Other: Placebo · Other: Glucagon and exendin 9-39
Glucagon (infusion of 5 ng·kg-1·min-1 from 0-60 minutes) and glucagon (infusion of 10 ng·kg-1 ·min-1 from 60-120 minutes) + a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-1·min-1 from -30-120 minutes).
Other: Glucagon · Other: Placebo · Other: Glucagon and exendin 9-39
NaCl (0.9%)
Other: Glucagon · Other: Placebo · Other: Glucagon and exendin 9-39
Glucagon infusion of 5 ng·kg-1·min-1 from 0-60 minutes and 10 ng·kg-1 ·min-1 from 60-120 minutes.
Placebo (0.9% NaCl).
Glucagon (infusion of 5 ng·kg-1·min-1 from 0-60 minutes) and glucagon (infusion of 10 ng·kg-1 ·min-1 from 60-120 minutes) + a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-1·min-1 from -30-120 minutes).
Natriuresis
From urine samples, unit mmol/L
Time frame: Analyzed from urine samples at -60, 0, 60 and 120 minutes
Glucagon extraction
From blood samples, unit pmol/L
Time frame: Analyzed from blood samples drawn at -30, 0, 20, 40, 60, 80, 100, 120, 140, 160 and 180 minutes
Glomerular filtration rate
Unit mL/min
Time frame: Measured via Fick's principle during steady state using [99mTc]Tc-DTPA (diethylene-triamine-pentaacetate) as a tracer given as a constant infusion from -210 to 180 min.
Diuresis
from urine samples, unit mL/min
Time frame: Analyzed from urine samples at -60, 0, 60 and 120 minutes
Renal Blood Flow
Unit mL/min
Time frame: Measured via Fick's principle during steady state using [99mTc]Tc-DTPA (diethylene-triamine-pentaacetate) as a tracer given as a constant infusion from -210 to 180 min.
Urea
Unit mg/dL
Time frame: Analyzed from blood samples drawn at -30, 0, 20, 40, 60, 80, 100, 120, 140, 160 and 180 minutes
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