Different Insulin Regimens and Postprandial Coagulation Activation

Esbjerg Hospital - University Hospital of Southern Denmark78 enrolled

Overview

The purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. The investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Cardiovascular Risk Hemostasis Inflammation Endothelial Function

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 30-75 years * BMI \> 25 kg/m2 * type 2 diabetes for more than 4 years * pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months * metformin with stable dose \>1000 mg/d for more than 12 weeks * acetylsalicylic acid (75 mg/d) for more than 2 weeks * no other anti-diabetic treatment 3 month previously * HbA1c\<8.5% at recruitment. Exclusion Criteria: * creatinine \> 120 µmol/l * ALAT /ASAT \> 2.5 x upper reference limit * use of anticoagulants within 1 month previously * any changes in dose of statins within 1 month previously * night work * present or planned pregnancy * mental sickness or alcohol abuse * clinically relevant major organ or systemic illness * uncontrolled hypertension \>180/110 mmHg * steroid treatment * known or suspected allergy to trial medications.

Outcomes

Primary Outcomes

Prothrombin fragment 1+2

Time frame: 7.40; 9.30; 11.30; 13.30; 15.30

Secondary Outcomes

C-reactive protein