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13C-Pyruvate Breath Test

NCT ID: NCT01807702

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12 hours and then undergo a breath test, have blood drawn, and cells from the inside of the mouth collected over a 12 hour period. The tests will be repeated at least a week later and subjects receive a dose of dichloroacetate (DCA)

Detailed Description

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Subjects will be screened with a history and physical and have baseline laboratory values drawn to assure that the subject is healthy.Subjects will fast for 12 hours before the test. The next day they will receive a dose of 25mg of pyruvate dissolved in 80ml of Crystal Light. The pyruvate used in this study will be prepared with a nonradioactive form of carbon, called a stable isotope. It poses no hazard to the subject's health. About 50 mls of blood will be drawn over a 120 minute time period from an IV catheter placed in the arm. Subjects will also be asked to exhale into a plastic tube about 12 times in 120 minutes to collect 13C carbon dioxide (13CO2). Cells from inside of the mouth will be collected by subjects swishing a tablespoon of mouth wash for one minute and then spitting it into a sterile plastic tube. At least one week following the first admission subjects will return to repeat the above procedure and receive 25mg of dichloroacetate (DCA) one hour before receiving the pyruvate. Then the same samples will be collected. Subjects have the option of doing the tests 4 times receiving the DCA on the last visit.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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13C-pyruvate,13C-Lactate and dichloroacetate

During the first day of the subjects participation pyruvate will be given and blood, breath and buccal cell samples will be collected over a two hour period. On the last day DCA will be given.

Group Type EXPERIMENTAL

13C-Pyruvate 13C-lactate and dichloroacetate

Intervention Type DRUG

Subjects will receive pyruvate and have blood,CO2, and buccal cell samples collected. The second visit the subjects will receive a dose of dichloroacetate before the pyruvate is given

Interventions

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13C-Pyruvate 13C-lactate and dichloroacetate

Subjects will receive pyruvate and have blood,CO2, and buccal cell samples collected. The second visit the subjects will receive a dose of dichloroacetate before the pyruvate is given

Intervention Type DRUG

Other Intervention Names

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dichloroacetate pyruvate CO2 collection

Eligibility Criteria

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Inclusion Criteria

* normal history,
* normal physical
* normal baseline laboratory data.

Exclusion Criteria

* Any illness
* Chronic health condition
* Use of street drugs
* Taking medication
* Abnormal labs Abnormal physical exam -
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter W. Stacpoole, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB# 654-10

Identifier Type: -

Identifier Source: org_study_id