Mitochondrial MyopathyNCT00004353
Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia
An observational study of Mitochondrial Myopathy and MELAS Syndrome, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic acidemia. II. Define the nature of the metabolic defect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitochondrial Myopathy, MELAS Syndrome, Lactic Acidosis
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1978to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
- Diagnostically documented elevation in lactate, pyruvate, and/or alanine levels in lactic acidemia patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego Medical Center
San Diego, California, 92103-8757
About this study
OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic acidemia.
II. Define the nature of the metabolic defect.
Read the detailed description
PROTOCOL OUTLINE: Patients fast for 6 hours. Glucagon IM is administered after the 6 hour fast. Glucose level is measured at 0, 15, 30, 45, 60, and 90 minutes.
In children of sufficient size, alanine and lactic acid should also be measured at each or most of these time points.
Fasting continues for at least 18 hours. Glucagon IM is administered again at end of fast. Glucose level is measured at time 0, 15, 30, 45, 60, and 90 minutes.
- Conditions
- Mitochondrial Myopathy, MELAS Syndrome, Lactic Acidosis
- Keywords
- MELAS syndrome, inborn errors of metabolism, lactic acidosis, mitochondrial myopathy, rare disease
- Medical subject headings
- Mitochondrial Myopathies, MELAS Syndrome, Acidosis, Lactic, Metabolism, Inborn Errors, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startDec 1978
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial MyopathyStudies 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
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of California, San Diego
- Investigators
- Richard H. Haas, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004353
- Sponsor's protocol ID
- NCRR-M01RR00827-0071
- Other IDs
- UCSD-071
- Status last verified
- Apr 2002
- First submitted
- 18 Oct 1999
- Last updated
- 10 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia
- ClinicalTrials.gov ID
- NCT00004353
- Acronym / sponsor ID
- NCRR-M01RR00827-0071
- Conditions
- Mitochondrial Myopathy, MELAS Syndrome, Lactic Acidosis
- Keywords
- MELAS syndrome, inborn errors of metabolism, lactic acidosis, mitochondrial myopathy, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of California, San Diego
- Study start
- Dec 1978
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic acidemia.
II. Define the nature of the metabolic defect.
Detailed description
PROTOCOL OUTLINE: Patients fast for 6 hours. Glucagon IM is administered after the 6 hour fast. Glucose level is measured at 0, 15, 30, 45, 60, and 90 minutes.
In children of sufficient size, alanine and lactic acid should also be measured at each or most of these time points.
Fasting continues for at least 18 hours. Glucagon IM is administered again at end of fast. Glucose level is measured at time 0, 15, 30, 45, 60, and 90 minutes.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 10 Jul 2008.
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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.
Richard H. Haas study chair
University of California, San Diego
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 Myopathy and MELAS Syndrome, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2008. 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.
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 10 Jul 2008.