Different Insulin Regimens and Postprandial Coagulation Activation

Type 2 Diabetes Clinical Trial

Official title:

Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053234
• Other study ID #: RRS 2006-1032
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Est. completion date: May 2007

Study information

• Verified date: October 2022
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk
• Diabetes Mellitus, Type 2
• Endothelial Function
• Hemostasis
• Inflammation
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Standardised meals

Locations

Country	Name	City	State
Denmark	Hospital of South West Denmark	Esbjerg

Sponsors (3)

Lead Sponsor	Collaborator
Hospital of South West Jutland	Novo Nordisk A/S, Ribe County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prothrombin fragment 1+2		7.40; 9.30; 11.30; 13.30; 15.30
Secondary	C-reactive protein		7.40; 9.30; 11.30; 13.30; 15.30