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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

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

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

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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