Different Insulin Regimens and Postprandial Coagulation A... | NCT01053234

Studies
Different Insulin Regimens and Postprandial Coagulation Activation

NCT01053234

Sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Status

Completed

Last Update Posted

Oct 19, 2022Actual

Enrollment

78Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes
Cardiovascular Risk
Hemostasis
Inflammation
Endothelial Function

Interventions

Standardised meals

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Jan 20, 2010

First Submission Date that Met QC Criteria

Jan 20, 2010

First Posted Date

Jan 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2022

Last Update Posted Date

Oct 19, 2022Actual

Name	Class
Ribe County Hospital	OTHER
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin aspart	Experimental		Dietary Supplement: Standardised meals
NPH insulin	Experimental		Dietary Supplement: Standardised meals

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standardised meals	Dietary Supplement		Insulin aspart NPH insulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prothrombin fragment 1+2		7.40; 9.30; 11.30; 13.30; 15.30

Secondary Outcomes

Measure	Description	Time Frame
C-reactive protein		7.40; 9.30; 11.30; 13.30; 15.30

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeppe Gram, Ph.D	Department of Medicine, Hospital of South West Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of South West Denmark		Esbjerg		6700	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D007249	Inflammation
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided