Wasting;Muscle(S)NCT03401944
Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.
A study testing TPN in people with Wasting;Muscle(S), run by Göteborg University at 1 site in Sweden.
Trial summary
The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Wasting;Muscle(S)
- What is being tested?
- TPN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2005to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major gastrointestinal surgery
- Assumed need of post-operative artificial nutrition.
Who cannot join
- Insulin dependent diabetes
- Steroid medication
Trial locations and contacts
1 site in 1 country.
About this study
The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition.
Read the 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.
- Conditions
- Wasting;Muscle(S)
- Being tested
- TPN, Control
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPNDrug
Also called TPN infusion
ControlOther
Also called Physiological saline infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TPN |
| Control (saline infusion) | Placebo comparator | Overnight infusion of physiological saline at the same infusion-rate; ml/kg as intervention (TPN). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single evaluation point at 12-14 hours following the start of overnight infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Jan 2005
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wasting;Muscle(S)Studies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kent Lundholm, Principal investigator, Department of Surgery, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401944
- Sponsor's protocol ID
- MB1+2
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.
- ClinicalTrials.gov ID
- NCT03401944
- Acronym / sponsor ID
- MB1+2
- Conditions
- Wasting;Muscle(S)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Parenteral Nutrition (TPN) | Active comparator | Drug: TPNOvernight infusion of Parenteral Nutrition supplied in all-in one bag -format. Infusion-rate of 0.16 gram Nitrogen/kg/day. |
| Control (saline infusion) | Placebo comparator | Other: ControlOvernight infusion of physiological saline at the same infusion-rate; ml/kg as intervention (TPN). |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major gastrointestinal surgery
- Assumed need of post-operative artificial nutrition.
Key exclusion criteria (2 listed)
- Insulin dependent diabetes
- Steroid medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPNAlso: TPN infusion | Drug | Total Parenteral Nutrition (TPN) |
| ControlAlso: Physiological saline infusion | Other | Control (saline infusion) |
Primary outcome
Muscle protein metabolism
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Lundholm principal investigator
Department of Surgery, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPN in people with Wasting;Muscle(S), run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein metabolism (time frame: Single evaluation point at 12-14 hours following the start of overnight infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.