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Clinical Trials/NCT00991575
NCT00991575
Completed
Not Applicable

Long Term Vascular Changes in Type 1 Diabetes, Clinical Aspects and Biological Markers

Oslo University Hospital1 site in 1 country33 target enrollmentApril 1, 2009
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ConditionsDiabetes Mellitus, Type 1ComplicationsCoronary Heart Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
Oslo University Hospital
Enrollment
33
Locations
1
Primary Endpoint
Fatal and non fatal cardiovascular disease (CVD) and stroke
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The main purpose of this study is to investigate progression of late complications of diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a long duration of the disease, and to define factors responsible for the progression of late complications.

Detailed Description

Despite intensively research in the field of hyperglycaemia and coronary heart disease in type 1 diabetes it is still not known in detail how hyperglycaemia leads to damage of the vessels. The aims of the present proposal are therefore two-fold: 1. To study in detail the progression of atherosclerosis (and micro vascular complications) in a well characterized cohort of type 1 diabetes with a long duration of the disease. This project will be a continuation of the Oslo study, a cohort started in 1982, with the last follow-up study in 1999/2000. 2. To define factors responsible for the progression of coronary heart disease (and micro vascular complications) in this cohort.

Registry
clinicaltrials.gov
Start Date
April 1, 2009
End Date
June 20, 2010
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kari Anne Sveen

MD

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Age 18-45 years
  • •Diagnosis of type 1 diabetes at \< 30 years of age, disease duration \> 7 but \< 30 years
  • •C-peptide \< 0, 1 nmol/l

Exclusion Criteria

  • •Serum creatinine \> 150 µmol/l
  • •Diastolic blood pressure \<100mmHg
  • •Overt nephropathy
  • •Proliferative retinopathy
  • •Pregnancy
  • •A history of neuropathy
  • •Other chronical disease
  • •Treatment with other drugs except insulin and oral contraceptives

Outcomes

Primary Outcomes

Fatal and non fatal cardiovascular disease (CVD) and stroke

Time Frame: One year

Secondary Outcomes

  • Vessel area stenosis(One year)

Study Sites (1)

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