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Trial record 3 of 68 for:    tpn

Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03401944
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Göteborg University

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.

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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

Resource links provided by the National Library of Medicine

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

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.

Information from the National Library of Medicine

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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

Inclusion Criteria:

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

Exclusion Criteria:

  • Insulin dependent diabetes
  • Steroid medication

Information from the National Library of Medicine

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 identifier (NCT number): NCT03401944

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Department of Surgery
Göteborg, Sweden, SE 41345
Sponsors and Collaborators
Göteborg University
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Principal Investigator: Kent Lundholm Department of Surgery, University of Gothenburg

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Responsible Party: Göteborg University Identifier: NCT03401944     History of Changes
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
Signs and Symptoms
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical