Type 1 Diabetes Mellitus Clinical Trial
Official title:
The Effect of Insulin-induced Hypoglycemia on Brain Lactate Accumulation and Regional Cerebral Blood Flow in Patients With Type 1 Diabetes Mellitus With and Without Hypoglycemia Unawareness and Non-diabetic Controls
Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people
with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of
habituation, characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia
unawareness, which in itself defines a particularly high risk of severe hypoglycemia. Recent
evidence suggest a pivotal role for increased brain lactate transport capacity in the
pathogenesis of hypoglycemia unawareness. However, there is uncertainty about the magnitude
of this effect and whether such excess brain lactate is oxidizes as a glucose-sparing
alternative energy source or acts as a metabolic regulator controlling brain glucose
metabolism, oxygen consumption and cerebral blood flow.
Objective: The primary objective of this study is to investigate the effect of hypoglycemia
on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary
objective is to assess whether this effect is a related to hypoglycemia unawareness or a
consequence of T1DM per se.
Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport
over the blood-brain barrier leading to cerebral lactate accumulation and that this lactate
accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical
hypoglycemia unawareness. Furthermore, the investigators expect that this effect of
hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow
(CBF).
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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