NCT03460899

Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus With Hypoglycemia
• Diabetes Mellitus, Type 2
• Hypoglycemia
• Hypoglycemic Episode

Interventions

Type	Name	Description
OTHER	Euglycaemic Clamp	All 14 subjects will undergo an euglycaemic clamp at Visit 2 with a plasma Glucose target of 5.5 mmol/L +/- 10% (4 timepoints for platelet activity parameter blood sampling)
OTHER	Hyperinsulinaemic/Hypoglycaemic Clamp	All 14 subjects will undergo a hypoglycaemic/hyperinsulinaemic clamp at Visit 3 with 4 timepoints for platelet activity Parameter blood sampling 30 minutes after reaching certain plasma glucose plateaus (5.5 mmol/L; 3.5 mmol/L; 2.5 mmol/L; after recovery again at 5.5 mmol/L)

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-06-11
• Completion: 2018-06-11
• First posted: 2018-03-09
• Last updated: 2019-11-18
• Results posted: 2019-11-18

Locations

1 site across 1 country: Austria