13C-Pyruvate Breath Test

NCT01807702 | Completed Phase 1

• 1 other identifier: IRB# 654-10
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Healthy

Keywords

dichloroacetate; pyruvate; lactate; pyruvate dehydrogenase

Outcome Measures

Primary Outcomes (1)

• Effect of dichloroacetate on pyruvate dehydrogenase and 13C02 production.

  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 Outcomes (2)

• Blood Lactate levels and 13CO2 Response to DCA

  Baseline to one year

• Conversion of 13C pyruvate to 13C pyruvate

  Baseline to One Year

Study Arms (1)

13C-pyruvate,13C-Lactate and dichloroacetate

EXPERIMENTAL

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

Interventions

13C-Pyruvate 13C-lactate and dichloroacetate 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

Also known as: dichloroacetate, pyruvate, CO2 collection

13C-pyruvate,13C-Lactate and dichloroacetate

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any illness
• Chronic health condition
• Use of street drugs
• Taking medication
• Abnormal labs Abnormal physical exam -

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Dichloroacetic Acid; Pyruvic Acid

Intervention Hierarchy (Ancestors)

Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Pyruvates; Keto Acids

Study Officials

• Peter W. Stacpoole, PhD, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: March 8, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)