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Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

Primary Purpose

Wasting;Muscle(S)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
TPN
Control
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wasting;Muscle(S)

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Insulin dependent diabetes
  • Steroid medication

Sites / Locations

  • Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Total Parenteral Nutrition (TPN)

Control (saline infusion)

Arm Description

Overnight infusion of Parenteral Nutrition supplied in all-in one bag -format. Infusion-rate of 0.16 gram Nitrogen/kg/day.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2017
Last Updated
January 22, 2018
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03401944
Brief Title
Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.
Official Title
Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2005 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wasting;Muscle(S)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total Parenteral Nutrition (TPN)
Arm Type
Active Comparator
Arm Description
Overnight infusion of Parenteral Nutrition supplied in all-in one bag -format. Infusion-rate of 0.16 gram Nitrogen/kg/day.
Arm Title
Control (saline infusion)
Arm Type
Placebo Comparator
Arm Description
Overnight infusion of physiological saline at the same infusion-rate; ml/kg as intervention (TPN).
Intervention Type
Drug
Intervention Name(s)
TPN
Other Intervention Name(s)
TPN infusion
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Physiological saline infusion
Primary Outcome Measure Information:
Title
Muscle protein metabolism
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major gastrointestinal surgery Assumed need of post-operative artificial nutrition. Exclusion Criteria: Insulin dependent diabetes Steroid medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Lundholm
Organizational Affiliation
Department of Surgery, University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
Göteborg
ZIP/Postal Code
SE 41345
Country
Sweden

12. IPD Sharing Statement

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Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

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