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Uptake and Utilization of Amino Acids by Splanchnic Bed

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Completed
CT.gov ID
NCT01032616
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
8
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Threonine Experimental: Study Period 1
  • Other: Lysine Experimental: Study Period 2
 Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Determination of the Difference in Uptake and Utilization of Two Amino Acids by the Splanchnic Bed
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Period 1

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

Other: Threonine Experimental: Study Period 1
Enteral and parenteral infusion of threonine isotope
Other Names:
  • Tracer Isotope - L-[1-13C]threonine

    		•
    Experimental: Study Period 2

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

    Other: Lysine Experimental: Study Period 2
    Both intravenous (iv) and intragastric (ig) Lysine isotopes.
    Other Names:
  • Tracer isotope - L-[1-13C]lysine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Breath VCO2 [-30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs]

    2. Blood CO2 [-30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Hospital for Sick Children Toronto Ontario Canada

    Sponsors and Collaborators

    • The Hospital for Sick Children

    Investigators

    • Principal Investigator: Paul Pencharz, MD, The Hospital for Sick Children

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Chapman, Clinical Research Nurse Specialist, The Hospital for Sick Children
    ClinicalTrials.gov Identifier:
    NCT01032616
    Other Study ID Numbers:
    • 0019880597 (Part b)
    First Posted:
    Dec 15, 2009
    Last Update Posted:
    Aug 5, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Karen Chapman, Clinical Research Nurse Specialist, The Hospital for Sick Children
    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 Results

    No Results Posted as of Aug 5, 2013