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Long Term Vascular Changes in Type 1 Diabetes (DM09)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University Hospital, Aker
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00991575
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition
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:

U.S. FDA Resources

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)
Groups/Cohorts
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.
  Eligibility

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.

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

Locations
Norway
Oslo University hospital, Aker
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Aker
Investigators
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
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013