An interventional study of Glucagon in Non-Alcoholic Fatty Liver Disease and Glucagon Resistance, sponsored by Malte Palm Suppli, MD. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Malte Palm Suppli, MD · Not applicable, Interventional, and Basic science
Many patients with type 2 diabetes exhibit elevated plasma concentrations of the glucose-mobilising pancreatic hormone glucagon; i.e. hyperglucagonaemia. This contributes to the hyperglycaemic state of the patients and is considered an important component in the pathophysiology of type 2 diabetes; but the mechanisms underlying this phenomenon remain unclear. The liver constitutes the main target organ of glucagon, and studies have shown that hyperglucagonaemia goes hand in hand with hyperaminoacidaemia and that both are associated with non-alcoholic fatty liver disease (NAFLD), independently of the presence of type 2 diabetes. In line with this, several recent studies support the existence of a feedback-cycle between the liver and the pancreatic alpha cells, governed by circulating glucagon and amino acids. The investigators hypothesise that the presence of hepatic steatosis results in hepatic glucagon resistance at the level of amino acid turnover, i.e. impaired glucagon-induced suppression of circulating amino acid concentrations. If this hypothesis proves correct, it would establish build-up of fat in the liver as a core mechanism underlying hyperglucagonaemia and, since the hyperglucagonemia is at least partly responsible for the fasting hyperglycaemia, as an important contributor to the hyperglycaemia of type 2 diabetes.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →This is the only study on the registry with Malte Palm Suppli, MD as lead sponsor.
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Exclusion Criteria:
20 healthy participants included in the arm for 3 experimental days each. On each experimental day infusions of stable isotope glucose (0,6 micromol/kg/min), glucagon (1 hour low; 0,6 ng/kg/min, 2 hours high; 4,0 ng/kg/min), somatostatin (450 micrograms/hour) and insulin (0,1 mU/kg/min) will be administered. Between the first two experimental days the participants will follow a sedentary lifestyle combined with a high-calorie diet intervention
Drug: Glucagon
Pancreatic clamp
Also known as: Insulin, Somatostatin, 6,6 H2-glucose
Nadir of the total amino acid concentration during a two-hour high physiological glucagon infusion during a pancreatic clamp with somatostatin
micromol/liter
Time frame: depending on the nadir between time 60 minutes and time 180 minutes
average slope of the curve describing the change in the total amino acid concentration during 'supraphysiological' glucagon infusion
micromol/liter/minute
Time frame: between time 60 minutes and time 180 minutes
the incremental area under the curve (iAUC) for total amino acid concentrations during 'supraphysiological' glucagon infusion
micromol/liter
Time frame: between time 60 minutes and time 180 minutes
the percentage change in amino acid concentration during the last hour of the 'supraphysiological' glucagon infusion as assessed by baseline subtracted AUC
micromol/liter
Time frame: between time 60 minutes and time 180 minutes
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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