Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

NCT ID: NCT03401944

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-01

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Wasting;Muscle(S)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

TPN

Intervention Type DRUG

Control (saline infusion)

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Interventions

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TPN

Intervention Type DRUG

Control

Intervention Type OTHER

Other Intervention Names

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TPN infusion Physiological saline infusion

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Insulin dependent diabetes
* Steroid medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kent Lundholm

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University of Gothenburg

Locations

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Department of Surgery

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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MB1+2

Identifier Type: -

Identifier Source: org_study_id

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