Long Term Vascular Changes in Type 1 Diabetes

NCT ID: NCT00991575

Last Updated: 2023-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-01

Study Completion Date

2010-06-20

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1 Complications Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes, type 1

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Aker

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kari Anne Sveen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristian F Hanssen, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Oslo university hospital, Aker, Norway

Locations

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Oslo University hospital, Aker

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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S-08843c/21262

Identifier Type: -

Identifier Source: secondary_id

916501

Identifier Type: -

Identifier Source: org_study_id

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