Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation
This experimental study is planned to investigate the impact of hypoglycaemia on platelet activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. The hypothesis that hypoglycaemia in patients with Diabetes Mellitus, Type 2 (T2DM) leads to increased platelet activation will be tested.
Increased platelet activation is significantly involved in the pathophysiology of micro- and
macrovascular diabetic complications. Previously performed studies suggested platelet
activation in both, hyper- and hypoglycaemic states, leading to a potentially increased risk
for thromboembolic complications. Hypoglycaemia, in particular severe hypoglycaemic episodes,
has been associated with increased cardiovascular or overall mortality in previous studies.
Potential mechanisms include arrhythmias or increased risk for thromboembolism, based on
platelet activation and/or hypercoagulability.
The aim of this experimental study is to investigate the impact of hypoglycaemia on platelet
activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. We
hypothesize that Hypoglycaemia in patients with T2DM leads to increased platelet activation.
The primary objective is to investigate platelet activation during different levels of
hypoglycaemia induced by a stepwise hyperinsulinaemic, hypoglycemic clamp experiment in
patients with T2DM.
Active study duration will be 5 days for each study participant. 14 subjects with T2DM
without history of cardiovascular events or manifest atherosclerosis will be enrolled. During
this monocentric, single arm, open, mechanistic trial platelet activation and recovery at one
week after the clamp experiment, changes of pro-atherothrombotic markers during the
hypoglycaemic clamp as well as counter regulatory hormone response during the clamp will be
investigated.
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