Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

Göteborg University

Status: Completed

Conditions: Wasting;Muscle(S)

Treatments: Other: Control; Drug: TPN

Study type: Interventional

Funder types: Other

Identifiers

NCT03401944

MB1+2

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Insulin dependent diabetes
• Steroid medication

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Total Parenteral Nutrition (TPN)

Active Comparator group

Description:

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

Treatment:

Drug: TPN

Control (saline infusion)

Placebo Comparator group

Description:

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

Treatment:

Other: Control