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Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

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ClinicalTrials.gov Identifier: NCT03401944
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Study Description
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Brief Summary:
The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition.

Condition or disease Intervention/treatment Phase
Wasting;Muscle(S) Drug: TPN Other: Control Not Applicable

Detailed Description:
Randomized study investigating alterations in muscle protein metabolism at provision of parenteral nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis. Patients scheduled for major gastrointestinal surgery are included. Muscle specimens are collected during surgery.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Total Parenteral Nutrition (TPN)
Overnight infusion of Parenteral Nutrition supplied in all-in one bag -format. Infusion-rate of 0.16 gram Nitrogen/kg/day.
 Drug: TPN
Other Name: TPN infusion
Placebo Comparator: Control (saline infusion)
Overnight infusion of physiological saline at the same infusion-rate; ml/kg as intervention (TPN).
 Other: Control
Other Name: Physiological saline infusion


Outcome Measures
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Primary Outcome Measures :
  1. Muscle protein metabolism [ Time Frame: Single evaluation point at 12-14 hours following the start of overnight infusion. ]
    Alterations in muscle protein metabolism will be assessed by various standard techniques for gene and protein expression. Combined measurements of cell-signaling molecules representing anabolic and catabolic signaling pathways will be evaluated in relation to transcription of muscle myosin proteins.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major gastrointestinal surgery
  • Assumed need of post-operative artificial nutrition.

Exclusion Criteria:

  • Insulin dependent diabetes
  • Steroid medication
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401944


Locations
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Sweden
Department of Surgery
Göteborg, Sweden, SE 41345
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Kent Lundholm Department of Surgery, University of Gothenburg
More Information
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03401944    
Other Study ID Numbers: MB1+2
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical