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Long Term Vascular Changes in Type 1 Diabetes (DM09)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Oslo University Hospital.
Recruitment status was:  Enrolling by invitation
University Hospital, Aker
Information provided by:
Oslo University Hospital 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 Complications 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 ]

Secondary Outcome Measures:
  • Vessel area stenosis [ Time Frame: One year ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its 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

Responsible Party: Kristian F. Hanssen, Professor MD, Oslo University hospital Identifier: NCT00991575     History of Changes
Other Study ID Numbers: 916501
Study First Received: October 7, 2009
Last Updated: October 7, 2009

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

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017