Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia

This study has been completed.

First Received on October 18, 1999. Last Updated on July 9, 2008 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of California, San Diego
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004353

Purpose

OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic acidemia.

II. Define the nature of the metabolic defect.

Condition
Mitochondrial Myopathy MELAS Syndrome Lactic Acidosis

Study Type:

Observational

Resource links provided by NLM:

Genetics Home Reference related topics: ataxia neuropathy spectrum childhood myocerebrohepatopathy spectrum deoxyguanosine kinase deficiency mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes mitochondrial neurogastrointestinal encephalopathy disease myoclonic epilepsy myopathy sensory ataxia myoclonic epilepsy with ragged-red fibers progressive external ophthalmoplegia succinic semialdehyde dehydrogenase deficiency

MedlinePlus related topics: Muscle Disorders

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	35
Study Start Date:	December 1978

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

Diagnostically documented elevation in lactate, pyruvate, and/or alanine levels in lactic acidemia patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004353

Locations

United States, California
University of California San Diego Medical Center
San Diego, California, United States, 92103-8757

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of California, San Diego

Investigators

Study Chair:

Richard H. Haas

University of California, San Diego

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004353 History of Changes
Other Study ID Numbers:	NCRR-M01RR00827-0071, UCSD-071
Study First Received:	October 18, 1999
Last Updated:	July 9, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

MELAS syndrome
inborn errors of metabolism
lactic acidosis
mitochondrial myopathy
rare disease

Additional relevant MeSH terms:

Acidosis
Acidosis, Lactic
Muscular Diseases
Mitochondrial Myopathies
MELAS Syndrome
Acid-Base Imbalance
Metabolic Diseases
Musculoskeletal Diseases
Neuromuscular Diseases

Nervous System Diseases
Mitochondrial Diseases
Mitochondrial Encephalomyopathies
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 13, 2012