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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
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 18, 1999
Last Updated
July 9, 2008
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of California, San Diego
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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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