Long Term Vascular Changes in Type 1 Diabetes (DM09)

This study is enrolling participants by invitation only.
University Hospital, Aker
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

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.

Diabetes Mellitus, Type 1
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Vascular Changes in Type 1 Diabetes, Clinical Aspects and Biological Markers

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Fatal and non fatal cardiovascular disease (CVD) and stroke [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vessel area stenosis [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, white cells, urine, tissue

Estimated Enrollment: 45
Study Start Date: April 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Diabetes, type 1

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.

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

This project will be a continuation of the previous cohort performed originally from 1982. The group or cohorts will be selected from primary care clinic.


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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991575

Oslo University hospital, Aker
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Aker
Principal Investigator: Kristian F Hanssen, Professor MD Oslo university hospital, Aker, Norway
  More Information

No publications provided

Responsible Party: Kristian F. Hanssen, Professor MD, Oslo University hospital
ClinicalTrials.gov Identifier: NCT00991575     History of Changes
Other Study ID Numbers: 916501, S-08843c/21262
Study First Received: October 7, 2009
Last Updated: October 7, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Diabetes mellitus, type1
cardiovascular disease
diabetes complications
Glycation end products, advanced

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 1
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014