Prevalence of Macrovascular Disease in Type 2 Diabetes Me... | NCT00298844

Studies
Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

NCT00298844

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

Mar 23, 2007Estimated

Enrollment

350

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus

Interventions

Not provided

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

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Jan 2010Estimated

First Submitted Date

Mar 1, 2006

First Submission Date that Met QC Criteria

Mar 1, 2006

First Posted Date

Mar 3, 2006Estimated

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

Mar 22, 2007

Last Update Posted Date

Mar 23, 2007Estimated

Description Module

Brief Summary

The study aim is to establish a consecutive population of newly referred type 2 diabetes mellitus patients and among these to describe the degree of macrovascular disease by evaluating left ventricular systolic and diastolic function (echocardiography), myocardial perfusion (single-photon emission computed tomography (SPECT)), the peripheral vascular perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a. carotis communis). Further, the degree of microvascular disease will be evaluated (glomerular filtration rate assessment, fundus photography and biotesiometry). Finally the cohort will be followed the next two years to assess the prognostic value of the above-mentioned parameters

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: ≥ 20 years.
Fasting C-peptide > 300 pmol/l.

Exclusion Criteria:

Verified medical history of macrovascular disease (stroke, myocardiac infarct, coronary revascularisation or strain gauge toe blood pressure < 30 mmHg).
Suspected short lifespan because of malignant disease or end-stage kidney disease.
Pregnancy or planned pregnancy during the study period.
Body weight > 150 kg.
Physical or mental disability not enabling participation in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mikael K. Poulsen, PhD student	Contact	+45 65414365		doc_mkp@hotmail.com
Jan E. Henriksen, MD, PhD	Contact	+45 65414364		jan.erik.henriksen@ouh.fyns-amt.dk

Overall Officials

Name	Affiliation	Role
Mikael K. Poulsen, PhD student	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital	Recruiting	Odense		5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25527236	Derived	Pedersen L, Nybo M, Poulsen MK, Henriksen JE, Dahl J, Rasmussen LM. Plasma calprotectin and its association with cardiovascular disease manifestations, obesity and the metabolic syndrome in type 2 diabetes mellitus patients. BMC Cardiovasc Disord. 2014 Dec 19;14:196. doi: 10.1186/1471-2261-14-196.
24076532	Derived

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