Long Term Vascular Changes in Type 1 Diabetes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00991575

Acronym

DM09

Enrollment

Registered

2009-10-08

Start date

2009-04-01

Completion date

2010-06-20

Last updated

2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, Coronary Heart Disease, Diabetes Mellitus, Type 1

Keywords

Diabetes mellitus, type1, cardiovascular disease, diabetes complications, Glycation end products, advanced

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Fatal and non fatal cardiovascular disease (CVD) and stroke	One year

Secondary

Measure	Time frame
Vessel area stenosis	One year

Countries

Norway

Outcome results