Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With Non-insulin-dependent Diabetes Mellitus (NIDDM)

Karolinska Institute

Status and phase

Completed

Phase 4

Conditions

Postprandial Hyperglycemia

Type 2 Diabetes Mellitus

Treatments

Drug: Insulin aspart (Novorapid®)

Study type

Interventional

Funder types

Other

Identifiers

NCT00771693

EudraCT number 2006-007031-27

Details and patient eligibility

About

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.

Full description

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.

15 minutes after glucose normalization, and right before the meal. 3. 90 minutes after the meal.

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.

Enrollment

18 patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type II Diabetes Mellitus.
Antecubital forearm veins allowing technically good sampling for platelet studies.
HbA1c 6-9 % (Mono-S method).
Below 70 years

Exclusion criteria

History of a cardiovascular disease; Ischemic heart disease, Stroke, Peripheral vascular disease.
Acute or chronic renal or liver disease
Contraindication to insulin treatment
Treatment with Glitazones, Sulphonylurea, antiplatelet drugs,
Thrombocytopenia <150 X109/l.