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Completed

NCT Number: NCT00991575

Long Term Vascular Changes in Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Cardiovascular Diseases Complications Coronary Disease Coronary Heart Disease Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Immune System Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University hospital, Aker

Oslo, 0514, Norway

About this study

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:

  • 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.
  • To define factors responsible for the progression of coronary heart disease (and micro vascular complications) in this cohort.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fatal and non fatal cardiovascular disease (CVD) and stroke

    Time frame: One year

Secondary outcomes

  1. Vessel area stenosis

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University Hospital, Aker

Registry information

Official study title

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

Acronym: DM09

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2009
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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