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NCT00991575 Clinical Trial

Long Term Vascular Changes in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

— DM09  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00991575
Other study ID # 916501
Secondary ID S-08843c/21262
Status Completed
Phase
First received
Last updated
Start date April 1, 2009
Est. completion date June 20, 2010

Study information
Verified date May 2023
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date June 20, 2010
Est. primary completion date May 20, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility The original criteria from 1982: 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University hospital, Aker Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital University Hospital, Aker

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fatal and non fatal cardiovascular disease (CVD) and stroke One year
Secondary Vessel area stenosis One year
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