- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053234
Different Insulin Regimens and Postprandial Coagulation Activation
October 18, 2022 updated by: Hospital of South West Jutland
Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Esbjerg, Denmark, 6700
- Hospital of South West Denmark
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Insulin aspart
|
|
Experimental: NPH insulin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prothrombin fragment 1+2
Time Frame: 7.40; 9.30; 11.30; 13.30; 15.30
|
7.40; 9.30; 11.30; 13.30; 15.30
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
C-reactive protein
Time Frame: 7.40; 9.30; 11.30; 13.30; 15.30
|
7.40; 9.30; 11.30; 13.30; 15.30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeppe Gram, Ph.D, Department of Medicine, Hospital of South West Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
January 20, 2010
First Submitted That Met QC Criteria
January 20, 2010
First Posted (Estimate)
January 21, 2010
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 18, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRS 2006-1032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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