13C-Pyruvate Breath Test (PBT)

November 30, 2015 updated by: University of Florida

13C-Pyruvate Breath Test Pilot Study

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- healthy volunteers

  • 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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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
Other Names:
  • dichloroacetate
  • pyruvate
  • CO2 collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of dichloroacetate on pyruvate dehydrogenase and 13C02 production.
Time Frame: Baseline to one year
Dichloroacetate is an activator of pyruvate dehydrogenase (PDH). It will be administered to the patient who will then undergo the pyruvate breath test to measure the amount of 13CO2 expressed. The activity of 13CO2 as measured by a concentration curve will reflect PDH activity.
Baseline to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Lactate levels and 13CO2 Response to DCA
Time Frame: Baseline to one year
There will be a correlation between blood lactate levels and 13CO2 in response to DCA administration by comparing CO2 breath peaks in the concentration curve compared to serum lactate levels for same time period.
Baseline to one year
Conversion of 13C pyruvate to 13C pyruvate
Time Frame: Baseline to One Year
There will be no reduction in the conversion of 13C-pyruvate to 13C-lactate in blood in response to DCA administration.
Baseline to One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 22, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB# 654-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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