Diabetes Mellitusdiabmito INCT00985101
Study of Cellular Impairments Involved in Diabetic Complications
An observational study of Diabetes Mellitus, run by Naestved Hospital.
Trial summary
The purpose of this study is to examine if an early detectable dysfunction in a cellular component (mitochondria) may predict complications in diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to not given
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatient diabetes clinic Naestved Hospital, denmark
Who may be able to join
- Diabetes mellitus
Who cannot join
- Age below 18 yrs
- Psychiatric disease
- Other metabolic disease
About this study
Official title: Study of the Significance of Mitochondrial Dysfunction for Development of Diabetic Complications
The purpose of this study is to examine if an early detectable dysfunction in a cellular component (mitochondria) may predict complications in diabetes mellitus.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
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 no complications | Not described | |
| diabetes with complications | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial damage
Measured: 3 times pr years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Case-control
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985101
- Sponsor's protocol ID
- SJ-109
- Acronym
- diabmito I
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Significance of Mitochondrial Dysfunction for Development of Diabetic Complications
- ClinicalTrials.gov ID
- NCT00985101
- Acronym / sponsor ID
- diabmito I / SJ-109
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- Apr 2010
- First posted
- 28 Sep 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 purpose of this study is to examine if an early detectable dysfunction in a cellular component (mitochondria) may predict complications in diabetes mellitus.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetes no complications | – | – |
| diabetes with complications | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient diabetes clinic Naestved Hospital, denmark
Key inclusion criteria (1 listed)
- Diabetes mellitus
Key exclusion criteria (3 listed)
- Age below 18 yrs
- Psychiatric disease
- Other metabolic disease
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
endothelial damage
Time frame: 3 times pr years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Naestved Hospital.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
endothelial damage (time frame: 3 times pr years). 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 27 Jul 2010.