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Uptake and Utilization of Amino Acids by Splanchnic Bed

NCT ID: NCT01032616

Last Updated: 2013-08-05

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-08-31

Brief Summary

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Splanchnic uptake and metabolism contributes significantly to the differences in flux seen between the intravenous and intragastric ingestion of certain indispensable amino acids.

This is the third in a series of studies designed to increase the investigators knowledge of the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed. In the initial two studies the investigators established the neonatal parenteral requirement of threonine and lysine. In the current study, the investigators will be examining the differences in uptake and metabolism of threonine and lysine across the splanchnic bed.

Detailed Description

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We propose that we will see a smaller amount of enterally fed isotopes reach the plasma as compared to the amount in plasma from the parenterally delivered isotopes. We also believe that the amount of enterally delivered threonine isotope that reaches the plasma will be significantly less than the amount of enterally fed lysine isotope.

Conditions

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Healthy Males

Keywords

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splanchnic bed theronine and lysine metabolism uptake isotopes metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed by Healthy Males

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study Period 1

AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences

Group Type EXPERIMENTAL

Threonine Experimental: Study Period 1

Intervention Type OTHER

Enteral and parenteral infusion of threonine isotope

Study Period 2

AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences

Group Type EXPERIMENTAL

Lysine Experimental: Study Period 2

Intervention Type OTHER

Both intravenous (iv) and intragastric (ig) Lysine isotopes.

Interventions

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Threonine Experimental: Study Period 1

Enteral and parenteral infusion of threonine isotope

Intervention Type OTHER

Lysine Experimental: Study Period 2

Both intravenous (iv) and intragastric (ig) Lysine isotopes.

Intervention Type OTHER

Other Intervention Names

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Tracer Isotope - L-[1-13C]threonine Tracer isotope - L-[1-13C]lysine

Eligibility Criteria

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Inclusion Criteria

* Healthy Males

Exclusion Criteria

* History of inborn error of metabolism
* Presence of a chronic disease
* Have unusual dietary practices
* Has recently lost weight
* Receiving pharmacological therapy or hormonal treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Karen Chapman

Clinical Research Nurse Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Pencharz, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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0019880597 (Part b)

Identifier Type: -

Identifier Source: org_study_id