NCT03401944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

10 years

First QC Date

December 21, 2017

Last Update Submit

January 22, 2018

Conditions

Wasting;Muscle(S)

Outcome Measures

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.

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

Study Arms (2)

Total Parenteral Nutrition (TPN)

ACTIVE COMPARATOR

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

Drug: TPN

Control (saline infusion)

PLACEBO COMPARATOR

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

Other: Control

Interventions

TPNDRUG
Also known as: TPN infusion
Total Parenteral Nutrition (TPN)
ControlOTHER
Also known as: Physiological saline infusion
Control (saline infusion)

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Insulin dependent diabetes
  • Steroid medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery

Gothenburg, SE 41345, Sweden

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Kent Lundholm

    Department of Surgery, University of Gothenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 17, 2018

Study Start

January 1, 2005

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

SE(1)