Type 1 Diabetes Mellitus With Hypoglycemia Clinical Trial
Official title:
The Effect of Intravenous Lactate Administration on Brain Lactate Concentrations and pH During Euglycemia and Hypoglycemia in Patients With Type 1 Diabetes With and Without Impaired Awareness of Hypoglycemia
Patients with type 1 diabetes (T1DM) who are unable to perceive symptoms of hypoglycemia,
referred to as impaired awareness of hypoglycemia (IAH), are at very high risk of severe
hypoglycemia. IAH affects approximately 25% of patients with T1DM. Brain lactate may be
involved in the development of IAH. A recent study indicated increased brain lactate
utilization during hypoglycemia in T1DM patients with IAH, which did not occur in patients
with normal awareness of hypoglycemia (NAH). Conversely, administration of lactate to
patients with NAH has been shown to attenuate counterregulatory hormone responses to and
symptomatic awareness of hypoglycemia, thus causing a situation that resembles IAH. It has,
however, not been demonstrated whether the excess of lactate is actually taken up or
metabolized by the brain, and if so whether this occurs under euglycemic or hypoglycemic
conditions or both.
This project consists of two related studies. The objective of part 1 is to investigate the
effect of elevated plasma lactate levels that are sufficient to impair awareness of
hypoglycemia on brain lactate concentrations during euglycemia and hypoglycemia in T1DM
patients with NAH. The objective of part 2 is to compare the effect of exogenous lactate on
brain lactate concentrations between T1DM patients with NAH and T1DM patients with IAH.
Furthermore, this study aims to determine the effect of acute hypoglycemia on the
inflammatory function and composition of peripheral blood mononuclear cells.
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