Long Term Vascular Changes in Type 1 Diabetes

Completed

• Conditions: Complications; Diabetes Mellitus, Type 1; Coronary Heart Disease

• Registration Number: NCT00991575
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2009-04-01
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Primary Completion: 2010-05-20
• Study Completion: 2010-06-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatal and non fatal cardiovascular disease (CVD) and stroke	One year

Secondary Outcome Measures

Name	Time	Method
Vessel area stenosis	One year

Trial Locations

Locations (1)

Oslo University hospital, Aker; 🇳🇴 Oslo, Norway