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CompletedNCT03401944Updated Jan 23, 2018

Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

An interventional study of TPN and Control in Wasting;Muscle(S), sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Göteborg University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study summary

The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition.

Read the 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.

02

Conditions studied

  • Wasting;Muscle(S)

Browse trials for

03

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Insulin dependent diabetes
  • Steroid medication
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Control (saline infusion)

    Overnight infusion of physiological saline at the same infusion-rate; ml/kg as intervention (TPN).

    Other: Control

Interventions

  • DrugTPN

    Also known as: TPN infusion

  • OtherControl

    Also known as: Physiological saline infusion

05

What researchers measure

Primary outcomes

  1. Muscle protein metabolism

    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.

    Time frame: Single evaluation point at 12-14 hours following the start of overnight infusion.

06

Study locations

1 site
  • Department of Surgery
    Göteborg, SE 41345, Sweden
07

Registry details

Key details

Study ID
NCT03401944
Lead sponsor
Göteborg University
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Jan 1, 2005
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014
Last update
Jan 23, 2018

Study contacts

Kent Lundholm
principal investigator · Department of Surgery, University of Gothenburg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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