Energy MetabolismNCT03917212
Energy Metabolism in Branched-chain Organic Acidemias
An observational study of Energy Metabolism and Metabolic Syndrome, run by German Diabetes Center at 2 sites in Germany.
Trial summary
Energy metabolism and insulin sensitivity were assessed in a case-control study in patients with branched-chain organic acidemias. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism, Metabolic Syndrome, Insulin Resistance
- How many people
- 57 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2012to Mar 2018
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with known propionic acidemia, methylmalonic acidemia or isovaleric acidemia were enrolled as well as healthy humans of comparable age, sex and BMI
Who may be able to join
- known branched-chain organic acidemia diagnosed by enzymatic or genetic test
- age>5 years
Who cannot join
- acute inflammatory conditions with fever, cold symptoms, gastro-intestinal infection within the last 24 hours
- contraindications for an oral glucose tolerance test such as fasting blood glucose >126 mg/dl, severe chronic gastrointestinal conditions, allergy against black currant
- contraindications for magnetic resonance tomography (MRT) such as claustrophobia, metallic implants which are not MRT compatible
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of General Pediatrics, Neonatology and Pediatric Cardiology of the University Children's Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia
Institute for Clinical Diabetology, German Diabetes Center
Düsseldorf, North Rhine-Westphalia
About this study
Official title: Non-invasive Measurement of Energy Metabolism in Patients With Primary and Secondary Mitochondrial Diseases
Energy metabolism and insulin sensitivity were assessed in a case-control study in patients with branched-chain organic acidemias.
Read the detailed description
Children and adults with branched-chain organic acidemias and matched healthy humans underwent deep metabolic phenotyping using non-invasive magnetic resonance spectroscopy, oral glucose tolerance tests and measurements of leucocyte respirometry in order to assess changes in energy metabolism and insulin sensitivity.
- Conditions
- Energy Metabolism, Metabolic Syndrome, Insulin Resistance
- Being tested
- No intervention
- Keywords
- Organic acidemias, Mitochondria, Oxidative stress, Fatty liver, Dyslipidemia
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Fatty Liver, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, observational study with metabolic characterisation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with propionic acidemia, isovaleric acidemia, methylmalonic acidemia Receives: Other: No intervention | |
| Controls | Healthy humans Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic and skeletal muscle energy metabolism
Hepatic and skeletal muscle energy metabolism assessed by magnetic resonance spectroscopy
Measured: At baseline
Secondary outcomes (1)
Insulin sensitivity
Insulin sensitivity measured from oral glucose tolerance test
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startMar 2012
- Primary completionNov 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy MetabolismStudies 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
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital, Düsseldorf
- Responsible party
- Sponsor
- Investigators
- Michael Roden, Professeor, Principal investigator, German Diabetes CenterRegina Ensenauer, Professor, Principal investigator, Children's Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917212
- Sponsor's protocol ID
- MITO-MRS
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Measurement of Energy Metabolism in Patients With Primary and Secondary Mitochondrial Diseases
- ClinicalTrials.gov ID
- NCT03917212
- Acronym / sponsor ID
- MITO-MRS
- Conditions
- Energy Metabolism, Metabolic Syndrome, Insulin Resistance
- Keywords
- Organic acidemias, Mitochondria, Oxidative stress, Fatty liver, Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Collaborators
- University Children's Hospital, Düsseldorf
- Study start
- Mar 2012 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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.
Energy metabolism and insulin sensitivity were assessed in a case-control study in patients with branched-chain organic acidemias.
Detailed description
Children and adults with branched-chain organic acidemias and matched healthy humans underwent deep metabolic phenotyping using non-invasive magnetic resonance spectroscopy, oral glucose tolerance tests and measurements of leucocyte respirometry in order to assess changes in energy metabolism and insulin sensitivity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: No interventionPatients with propionic acidemia, isovaleric acidemia, methylmalonic acidemia |
| Controls | – | Other: No interventionHealthy humans |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with known propionic acidemia, methylmalonic acidemia or isovaleric acidemia were enrolled as well as healthy humans of comparable age, sex and BMI
Key inclusion criteria (2 listed)
- known branched-chain organic acidemia diagnosed by enzymatic or genetic test
- age>5 years
Key exclusion criteria (3 listed)
- acute inflammatory conditions with fever, cold symptoms, gastro-intestinal infection within the last 24 hours
- contraindications for an oral glucose tolerance test such as fasting blood glucose >126 mg/dl, severe chronic gastrointestinal conditions, allergy against black currant
- contraindications for magnetic resonance tomography (MRT) such as claustrophobia, metallic implants which are not MRT compatible
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 |
|---|---|---|
| No interventionNo intervention, observational study with metabolic characterisation | Other | Controls, Patients |
Primary outcome
Hepatic and skeletal muscle energy metabolism
Time frame: At baseline
Hepatic and skeletal muscle energy metabolism assessed by magnetic resonance spectroscopy
1 secondary outcome
Insulin sensitivity
Time frame: At baseline
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 16 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Michael Roden, Professeor principal investigator
German Diabetes Center
Regina Ensenauer, Professor principal investigator
Children's Hospital Düsseldorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Energy Metabolism and Metabolic Syndrome, run by German Diabetes Center at 2 sites in Germany.
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 2 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: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Hepatic and skeletal muscle energy metabolism (time frame: At baseline). 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 16 Apr 2019.