Type 1 Diabetes Mellitus Clinical Trial
Official title:
The Effect of Exercise-induced Hyperlacticacidemia on Counterregulatory Responses, Symptoms, Cognitive Function and Brain Lactate Accumulation During Hypoglycemia in (Hypoglycemic Unaware)Type I Diabetes Patients and Normal 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, eventually leading to
hypoglycemia unawareness, which creates a particularly high risk of severe hypoglycemia.
Recent evidence suggest a pivotal role for (brain) lactate in the pathogenesis of
hypoglycemia unawareness. Indeed, exogenous lactate administration may preserve brain
function and attenuate counterregulatory responses to and symptomatic awareness of
hypoglycemia. It is unknown whether endogenous elevation of plasma lactate produces the same
effects and whether such effects differ between patients with T1DM with and without
hypoglycemia unawareness and healthy controls.
Objective: To investigate the effect of elevated levels of endogenous lactate on brain
lactate accumulation and on counterregulatory responses to, symptomatic awareness of and
cognitive function during hypoglycemia in patients with T1DM with and without hypoglycemia
unawareness and normal controls.
Hypothesis: The investigators hypothesize first that endogenous lactate, when raised through
high intensity exercise, preserves neuronal metabolism during subsequent hypoglycemia, which
in turn will attenuate counterregulatory hormone responses, appearance of symptoms and
deterioration of cognitive function. Second, the investigators posit that these effects will
be augmented in patients with hypoglycemia unawareness compared to healthy subjects and T1DM
patients with normal awareness as a consequence of greater transport capacity of lactate
into the brain.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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