Mitochondrial DiseaseNCT00786539
Mitochondria Inborn Errors of Metabolism and ANT Defects in Mitochondria Diseases
An observational study of Mitochondrial Disease, run by University of California, Irvine at 1 site in United States.
Trial summary
The objective of this research protocol is to continue investigation of the nature and prevalence of mitochondria disease and to aid patients and health care providers in the understanding of these complex disorders. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Mitochondrial Disease
- What is being tested?
- Diffuse Optical Spectroscopy
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to May 2015
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population with mitochondrial disorder and/or their relatives will be referred to MITOMED by Primary Care Physicians or by Clinical Specialists.
Who may be able to join
- Male or female all ages group with diagnosis of mitochondrial disorder
Who cannot join
- Subjects with visual, auditory and/or neurological problems known to result from toxic or environmental effects
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute Medical clinic
Irvine, California, 92612
About this study
Official title: Investigation of the Nature and Prevalence of Mitochondria Disease
The objective of this research protocol is to continue investigation of the nature and prevalence of mitochondria disease and to aid patients and health care providers in the understanding of these complex disorders.
This research study brings together many clinical sub-specialists to address the etiology of these disorders and to develop more effective approaches for their diagnoses and more reliable prognoses.
Read the detailed description
The non-invasive device named Diffuse Optical Spectroscopy developed at the Beckman Laser Institute is to be used to measure various physiological parameters. Since mitochondria produce most of the energy necessary for cellular function, their efficacy is most important for systems with a high energy demand like the brain, heart, skeletal muscle, kidney, liver, and endocrine tissues. As a result, mitochondria diseases usually manifest as complex, multi-organ disorders, requiring multispecialty investigations.
- Conditions
- Mitochondrial Disease
- Being tested
- Diffuse Optical Spectroscopy
- Keywords
- mitochondrial
- Medical subject headings
- Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse Optical SpectroscopyDevice
mitochondria
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of Mitochondrial diseases
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startOct 2006
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Bruce J Tromberg, PhD, Principal investigator, Beckman Laser Institute University of California IrvineVirginia Kimonis, MD, Principal investigator, UCIMC Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786539
- Sponsor's protocol ID
- 20022608
- Status last verified
- Oct 2022
- First submitted
- 4 Nov 2008
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Nature and Prevalence of Mitochondria Disease
- ClinicalTrials.gov ID
- NCT00786539
- Acronym / sponsor ID
- 20022608
- Conditions
- Mitochondrial Disease
- Keywords
- mitochondrial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Oct 2006
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Nov 2008 (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 objective of this research protocol is to continue investigation of the nature and prevalence of mitochondria disease and to aid patients and health care providers in the understanding of these complex disorders.
This research study brings together many clinical sub-specialists to address the etiology of these disorders and to develop more effective approaches for their diagnoses and more reliable prognoses.
Detailed description
The non-invasive device named Diffuse Optical Spectroscopy developed at the Beckman Laser Institute is to be used to measure various physiological parameters. Since mitochondria produce most of the energy necessary for cellular function, their efficacy is most important for systems with a high energy demand like the brain, heart, skeletal muscle, kidney, liver, and endocrine tissues. As a result, mitochondria diseases usually manifest as complex, multi-organ disorders, requiring multispecialty investigations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population with mitochondrial disorder and/or their relatives will be referred to MITOMED by Primary Care Physicians or by Clinical Specialists.
Key inclusion criteria (1 listed)
- Male or female all ages group with diagnosis of mitochondrial disorder
Key exclusion criteria (1 listed)
- Subjects with visual, auditory and/or neurological problems known to result from toxic or environmental effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffuse Optical Spectroscopymitochondria | Device | – |
Primary outcome
Symptoms of Mitochondrial diseases
Time frame: Up to 12 weeks
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 20 Oct 2022.
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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.
Bruce J Tromberg, PhD principal investigator
Beckman Laser Institute University of California Irvine
Virginia Kimonis, MD principal investigator
UCIMC Pediatrics
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 Mitochondrial Disease, run by University of California, Irvine at 1 site in United States.
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 1 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 20 Oct 2022. 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 United States. 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?
Symptoms of Mitochondrial diseases (time frame: Up to 12 weeks). 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 20 Oct 2022.