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Clinical Trial Details

Trial ID: L4072
Source ID: NCT02205996
Associated Drug: Insulin (Humulin S)
Title: The Effects of Hypoglycaemia in People With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin (Humulin S)|DEVICE: Euglycaemic Hypoglycaemic Insulin clamp
Outcome Measures: Primary: To examine the effect of hypoglycaemia on platelet surface expression of platelet activation markers P-selectin and fibrinogen binding., Platelet surface expression of activation markers, P-selectin and fibrinogen binding, were measured in the resting state (unstimulated samples) and in response to stimulation with platelet agonist adenosine diphosphate, and platelet inhibitor prostacyclin. A change in platelet function from times 0 (baseline), to 2 hours (euglycaemia), 4 hours (hypoglycaemia) and 24 hours after the clamp studies was measured and compared between the two groups., Up to 24 hours after euglycaemic hypoglycaemic clamp | Secondary: To measure changes in markers of inflammation (high sensitivity C-reactive protein) and endothelial function using EndoPat 2000, High sensitivity C-reactive protein was measured at baseline (time 0), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and 24 hours after clamp studies. Changes from baseline were compared between the groups. EndoPat was measured before the insulin clamp and 24 hours afterwards and changes were compared between the two groups., Up to 24h after euglycaemic hypoglycaemic clamp | Other: To assess the effects of hypoglycaemia on participants scores on cognitive function tests, Three cognitive function tests (Tower of Hanoi; Dual Task test and The Digit symbol-coding) were measured at baseline (time 0), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and 24 hours after insulin clamp studies. Changes from baseline in each of these tests in response to the insulin clamp were compared between the two groups., Up to 24h after euglycaemic hypoglycaemic clamp
Sponsor/Collaborators: Sponsor: University of Hull | Collaborators: Hull University Teaching Hospitals NHS Trust
Gender: ALL
Age: ADULT
Phases:
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2011-11
Completion Date: 2013-05
Results First Posted:
Last Update Posted: 2014-08-01
Locations: Hull Royal Infirmary, Hull, HU3 2RW, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02205996