Diabetes After Total Pancreatectomy Clinical Trial
Official title:
The Impact of Lixisenatide on Postprandial Glucose Tolerance in Pancreatectomised Subjects -a Delineation of Extrapancreatic Effects
Postprandial glucose (PPG) excursions are not only determined by insulin-mediated glucose
disposal and endogenous glucose production (regulated by insulin and glucagon); also the rate
of gastric emptying constitutes an important determinant of PPG levels 1. The short-acting
glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide is used in the treatment of
type 2 diabetes. It increases glucose-dependent insulin secretion, suppresses glucagon
secretion and reduces gastric emptying of meals 2. These three mechanisms most likely
constitute the weightiest mechanisms behind the potent impact of lixisenatide on exaggerated
PPG excursions in patients with type 2 diabetes - which often are normalised during
lixisenatide treatment 3. However, the separate impact of lixisenatide-induced reduction of
gastric emptying (independently of the pancreatic effects) has been difficult to determine.
Importantly, treatment with lixisenatide also decreases appetite and food intake and may,
like native GLP-1, increase energy expenditure 4. So far an exact demarcation of the
pancreatic and extrapancreatic effects of lixisenatide in humans remains to be established.
The present project serves to determine whether effects of lixisenatide on gastric emptying,
appetite, food intake and resting energy expenditure are dependent on the endocrine pancreas.
The study is a randomised, placebo-controlled, double-blinded, cross-over study.
12 healthy persons and 12 pancreatectomized patients (i.e. patients who have had their
pancreata removed due to pancreatic cancer or severe chronic pancreatitis) will be subjected
to two experimental days on which they will undergo a liquid meal test followed by a fasting
period and finished off with an ad libitum meal with lixisenatide and placebo, respectively.
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