Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

Not Applicable

Completed

• Conditions: Wasting;Muscle(S)
• Interventions: Drug: TPN; Other: Control

• Registration Number: NCT03401944
• Lead Sponsor: Göteborg University

Brief Summary

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

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 Timeline

• Study Start: 2005-01-01
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Study First Submitted: 2017-12-21
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

• Insulin dependent diabetes
• Steroid medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Parenteral Nutrition (TPN)	TPN	Overnight infusion of Parenteral Nutrition supplied in all-in one bag -format. Infusion-rate of 0.16 gram Nitrogen/kg/day.
Control (saline infusion)	Control	Overnight infusion of physiological saline at the same infusion-rate; ml/kg as intervention (TPN).

Primary Outcome Measures

Name	Time	Method
Muscle protein metabolism	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.

Trial Locations

Locations (1)

Department of Surgery; 🇸🇪 Göteborg, Sweden