Study of the Metabolism of Pyruvate and Related Problems... | NCT00004353

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

NCT00004353

Sponsor

National Center for Research Resources (NCRR)

Status

Completed

Last Update Posted

Jul 10, 2008Estimated

Enrollment

35Estimated

Phase

Not provided

Conditions

Mitochondrial Myopathy
MELAS Syndrome
Lactic Acidosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UCSD-071

Status Module

Record Verification Date

Apr 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1978

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 1999

First Submission Date that Met QC Criteria

Oct 18, 1999

First Posted Date

Oct 19, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2008

Last Update Posted Date

Jul 10, 2008Estimated

Name	Class
University of California, San Diego	OTHER

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Eligibility Module

Eligibility Criteria

PROTOCOL ENTRY CRITERIA:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard H. Haas	University of California, San Diego	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego Medical Center		San Diego	California	92103-8757	United States

Condition Browse Module

MeSH Terms

ID	Term
D017240	Mitochondrial Myopathies
D017241	MELAS Syndrome
D000140	Acidosis, Lactic
D008661	Metabolism, Inborn Errors
D035583	Rare Diseases

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided