Different Insulin Regimens and Postprandial Coagulation Activation

Not Applicable

Completed

• Conditions: Hemostasis; Type 2 Diabetes; Endothelial Function; Cardiovascular Risk; Inflammation
• Interventions: Dietary Supplement: Standardised meals

• Registration Number: NCT01053234
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPH insulin	Standardised meals	-
Insulin aspart	Standardised meals	-

Primary Outcome Measures

Name	Time	Method
Prothrombin fragment 1+2	7.40; 9.30; 11.30; 13.30; 15.30

Secondary Outcome Measures

Name	Time	Method
C-reactive protein	7.40; 9.30; 11.30; 13.30; 15.30

Trial Locations

Locations (1)

Hospital of South West Denmark; 🇩🇰 Esbjerg, Denmark