Diabetes Mellitus, Type 1DM09NCT00991575
Long Term Vascular Changes in Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Complications, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Complications, Coronary Heart Disease
- How many people
- 33 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2009to 20 Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Vascular Changes in Type 1 Diabetes, Clinical Aspects and Biological Markers
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.
Read the 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:
- 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.
- Keywords
- Diabetes mellitus, type1, cardiovascular disease, diabetes complications, Glycation end products, advanced
- Medical subject headings
- Diabetes Mellitus, Type 1, Coronary Disease, Diabetes Mellitus, Cardiovascular Diseases, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes, type 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatal and non fatal cardiovascular disease (CVD) and stroke
Measured: One year
Secondary outcomes (1)
Vessel area stenosis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study start1 Apr 2009
- Primary completion20 May 2010
- Study completion20 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Aker
- Responsible party
- Principal investigator, Kari Anne Sveen, Oslo University Hospital
- Investigators
- Kristian F Hanssen, Professor MD, Principal investigator, Oslo university hospital, Aker, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991575
- Sponsor's protocol ID
- 916501
- Other IDs
- S-08843c/21262
- Acronym
- DM09
- Status last verified
- May 2023
- First submitted
- 7 Oct 2009
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Vascular Changes in Type 1 Diabetes, Clinical Aspects and Biological Markers
- ClinicalTrials.gov ID
- NCT00991575
- Acronym / sponsor ID
- DM09 / 916501
- Keywords
- Diabetes mellitus, type1, cardiovascular disease, diabetes complications, Glycation end products, advanced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Aker
- Study start
- 1 Apr 2009
- Primary completion
- 20 May 2010 (actual)
- Study completion
- 20 Jun 2010 (actual)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes, type 1 | – | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Serum creatinine > 150 µmol/l
- Diastolic blood pressure <100mmHg
- Overt nephropathy
- Proliferative retinopathy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatal and non fatal cardiovascular disease (CVD) and stroke
Time frame: One year
1 secondary outcome
Vessel area stenosis
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian F Hanssen, Professor MD principal investigator
Oslo university hospital, Aker, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Complications, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatal and non fatal cardiovascular disease (CVD) and stroke (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.