A Phase 4 interventional study of Insulin aspart (Novorapid®) in Type 2 Diabetes Mellitus and Postprandial Hyperglycemia, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Karolinska Institutet · Phase 4, Interventional, and Basic science
The postprandial phase in diabetic patients is characterized by a rapid increase in blood glucose levels, increase in platelet aggregation, LDL oxidation and over production of thrombin.
The aim of the study is to determine whether meal induced platelet activation is related to post-prandial hyperglycemia, and can be attenuated by good postprandial glucose control with rapidly acting insulin in patients with T2DM.
Each patient is admitted in the fasting state, on 3 different occasions . Blood glucose levels are normalized using intravenous infusion of insulin aspart , to a blood glucose level of 6-7 mmol/l. 15 minutes after normalization ,and right before a standardized meal, the patient is given a subcutaneous injection of insulin aspart 0.1 U/kg, 0.2 U/kg or placebo. The order of injections in the cross over study is randomized and blinded to the patient and to the investigators. The patient eats the meal and is followed up for 90 minutes after completion of the meal.
Blood tests for platelet function and other parameters are taken at 3 main points: 1. before glucose normalization.
Platelet function is evaluated by flow cytometry in whole blood (P- Selectin expression, Fibrinogen binding,aggregate formation: platelet- leukocyte, platelet-platelet, platelet-monocyte). Agonists that are used for platelet activation in flow cytometry are the thromboxane analogue U46619, ADP, and a collagen peptide that activates GPVI. Platelet adhesion is measured by the IMPACT cone and platelet analyser.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 18 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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a cross-over study with subcutaneous injection of insulin aspart 0.1U/kg, 0.2u/kg or placebo, before the meal, on 3 different occasions.
Also known as: NovoRapid (Novo-Nordisk)
To evaluate if platelet activation following a carbohydrate rich meal is related to the post-prandial hyperglycemia, and thus can be attenuated by premeal insulin treatment in patients with T2DM.
Time frame: 90 minutes after the meal
Co- primary platelet response variables: U46619 stimulated platelet P- selectin activation, platelet-leukocyte aggregation, platelet-platelet aggregates and platelet-monocyte aggregates.
Time frame: After completion of the study in 20 patients
To elucidate if short-term lowering of blood glucose by insulin infusion (pretreatment standardization of blood glucose) reduces platelet activity in patients with T2DM.
Time frame: After completion of the glucose normalization (before the meal)
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet