Type 1 Diabetes Clinical Trial
Official title:
The Influence of Ambient Glycemia on the Effect of Pramlintide on Gastric Emptying in Patients With Type 1 Diabetes and Healthy Subjects
• To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated with subcutaneous (SC) injections of pramlintide.
Postprandial increases in plasma glucose concentrations are mainly determined by the degree
of postprandial suppression of endogenous glucose production and the rate of appearance of
the ingested glucose. The latter is predominantly determined by the amount of glucose taken
up by the splanchnic bed. Because nutrient absorption depends on gastric nutrient delivery,
gastric emptying rate is a key determinant of the early rise of plasma glucose
postprandially. At mealtime, the faster the stomach empties the more rapid the rise in
plasma glucose. Yet, plasma glucose concentration is a determinant of gastric emptying rate.
In non-diabetic subjects, as plasma glucose rises and approaches the upper limit of the
normal range (~140 mg/dl), gastric emptying slows. This likely represents a physiological
brake mechanism to limit excess delivery of nutrients, thus avoiding excessive appearance of
glucose in plasma. In diabetes, abnormally accelerated gastric emptying as well as delayed
gastric emptying have been reported. These conflicting data may be explained by differences
of ambient glycaemia. In most of these studies undertaken in diabetic subjects these
patients were severely hyperglycaemic, thus the reported delayed gastric emptying may be
explained by the effect of hyperglycaemia on gastric motility. Indeed, a small number of
studies controlled for ambient glycaemia found acceleration of gastric emptying in diabetes
and suggest that diabetes manifests with a maladaptive acceleration of gastric emptying
likely contributing to excessive postprandial plasma glucose excursions.
The amylin analog pramlintide is a potential new therapeutic that elicits a potent glucose
lowering effect in the postprandial period thought to be due to both a suppression of plasma
glucagon and a delay of gastric emptying. It is not clear, however, to what extent the
pramlintide-induced delay of gastric emptying offsets a potential maladaptive acceleration
of gastric emptying in diabetes patients studied under controlled glycemic conditions. In
theory, every drug that reduces hyperglycaemia should accelerate gastric emptying and,
thereby, minimize its potential effect on postprandial hyperglycaemia. Thus, the
drug-induced effect of amylin on gastric motility may be of great advantage by offset the
effects of glycemic induced acceleration on gastric emptying.
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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