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

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

July 9, 2008

Start Date ^ICMJE

December 1978

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Mitochondrial Myopathy
MELAS Syndrome
Lactic Acidosis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004353

Responsible Party

Study ID Numbers ^ICMJE

NCRR-M01RR00827-0071, UCSD-071

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

University of California, San Diego

Investigators ^ICMJE

Study Chair:

Richard H. Haas

University of California, San Diego

Information Provided By

National Center for Research Resources (NCRR)

Verification Date

April 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP