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Different Insulin Regimens and Postprandial Coagulation Activation

Primary Purpose

Type 2 Diabetes, Cardiovascular Risk, Hemostasis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Standardised meals
Sponsored by
Hospital of South West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Hyperglycaemia, Postprandial, Type 2 diabetes, Cardiovascular risk markers

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of South West Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Insulin aspart

NPH insulin

Arm Description

Outcomes

Primary Outcome Measures

Prothrombin fragment 1+2

Secondary Outcome Measures

C-reactive protein

Full Information

First Posted
January 20, 2010
Last Updated
October 18, 2022
Sponsor
Hospital of South West Jutland
Collaborators
Ribe County Hospital, Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01053234
Brief Title
Different Insulin Regimens and Postprandial Coagulation Activation
Official Title
Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital of South West Jutland
Collaborators
Ribe County Hospital, Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Cardiovascular Risk, Hemostasis, Inflammation, Endothelial Function
Keywords
Hyperglycaemia, Postprandial, Type 2 diabetes, Cardiovascular risk markers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin aspart
Arm Type
Experimental
Arm Title
NPH insulin
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Standardised meals
Primary Outcome Measure Information:
Title
Prothrombin fragment 1+2
Time Frame
7.40; 9.30; 11.30; 13.30; 15.30
Secondary Outcome Measure Information:
Title
C-reactive protein
Time Frame
7.40; 9.30; 11.30; 13.30; 15.30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeppe Gram, Ph.D
Organizational Affiliation
Department of Medicine, Hospital of South West Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of South West Denmark
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark

12. IPD Sharing Statement

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Different Insulin Regimens and Postprandial Coagulation Activation

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