NCT00991575

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2010

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

October 7, 2009

Last Update Submit

May 5, 2023

Conditions

Diabetes Mellitus, Type 1ComplicationsCoronary Heart Disease

Keywords

Diabetes mellitus, type1cardiovascular diseasediabetes complicationsGlycation end products, advanced

Outcome Measures

Primary Outcomes (1)

  • Fatal and non fatal cardiovascular disease (CVD) and stroke

    One year

Secondary Outcomes (1)

  • Vessel area stenosis

    One year

Study Arms (1)

Diabetes, type 1

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University hospital, Aker

Oslo, 0514, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, urine, tissue

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Coronary DiseaseDiabetes MellitusCardiovascular DiseasesDiabetes Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMyocardial IschemiaHeart DiseasesVascular Diseases

Study Officials

  • Kristian F Hanssen, Professor MD

    Oslo university hospital, Aker, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

April 1, 2009

Primary Completion

May 20, 2010

Study Completion

June 20, 2010

Last Updated

May 8, 2023

Record last verified: 2023-05

Locations

NO(1)