Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia
Primary Purpose
Mitochondrial Myopathy, MELAS Syndrome, Lactic Acidosis
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Mitochondrial Myopathy focused on measuring MELAS syndrome, inborn errors of metabolism, lactic acidosis, mitochondrial myopathy, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: Diagnostically documented elevation in lactate, pyruvate, and/or alanine levels in lactic acidemia patients
Sites / Locations
- University of California San Diego Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004353
First Posted
October 18, 1999
Last Updated
July 9, 2008
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00004353
Brief Title
Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia
Study Type
Observational
2. Study Status
Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
December 1978 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of California, San Diego
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondrial Myopathy, MELAS Syndrome, Lactic Acidosis
Keywords
MELAS syndrome, inborn errors of metabolism, lactic acidosis, mitochondrial myopathy, rare disease
7. Study Design
Enrollment
35 (Anticipated)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
Diagnostically documented elevation in lactate, pyruvate, and/or alanine levels in lactic acidemia patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard H. Haas
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8757
Country
United States
12. IPD Sharing Statement
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Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia
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