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Human Protein Turnover Project


- candidate number22009
- NTR NumberNTR5147
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2015
- Secondary IDsNL51743.096.14 
- Public TitleHuman Protein Turnover Project
- Scientific TitleHuman Protein Turnover Project (HuPTuP)
- ACRONYMHuPTuP
- hypothesis1. Organ-specific protein synthesis rates will be higher than muscle protein synthesis rates.
2. Tumor-specific protein synthesis rates will be higher than organ-specific protein synthesis rates.
- Healt Condition(s) or Problem(s) studiedProtein
- Inclusion criteria- age 18 to 85 years
- Compos mentis
- Surgical intervention for oesophagus carcinoma, colon carcinoma, aortic valve insufficiency, lung carcinoma, renal rell carcinoma, epilepsy or hip fracture.
- Written informed consent
- Exclusion criteria- Co-morbidities and neuromuscular disorders of the lower limbs severely interacting with mobility with limited or no opportunity for improvement (e.g. cerebral palsy);
- Peripheral arterial disease Fontaine III or IV;
- Chronic obstructive pulmonary disease (COPD) GOLD III or IV;
- Use of systemic steroids in the past four weeks, other than indicated for the specific type of surgery;
- Use anti-inflammatory biologicals (e.g. TNF-alfa blockers) in the past four weeks;
- Phenylketonuria (PKU);
- Surgical intervention in the past four weeks;
- Insulin dependent diabetes mellitus;
- Total parenteral nutrition at day of surgery;
- Pregnancy;
- Neoadjuvant chemo- or radiotherapy in the past four weeks;
- Organ-specific exclusion criteria (see below).

Organ specific exclusion criteria:
Heart:
- Medical history of ischemic heart disease
- heart failure
Kidney:
- Diabetes Mellitus
- GFR < 20 ml/min/1.73 m2
Bone:
- Life expectancy <6 months
- Time to surgery >48 hours.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 4-mei-2015
- planned closingdate31-dec-2017
- Target number of participants35
- Interventionsnone
- Primary outcomeFractional synthetic rate (FSR) and enrichment (MPE) in vastus lateralis and organ tissue.
- Secondary outcomeFractional synthetic rate (FSR) and enrichment (MPE) in tumor tissue, compared to organ tissue.
- TimepointsSeveral Blood draws before and during surgery. Tissue sample during surgery at the moment tissue is removed.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Joey Smeets
- CONTACT for SCIENTIFIC QUERIESDrs. Joey Smeets
- Sponsor/Initiator Atrium Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)CHANGE 11-aug-2015-EB:

Inclusion NEW:
- age 18 to 85 years
- Compos mentis
- Surgical intervention for oesophagus carcinoma, colon carcinoma, aortic valve insufficiency, lung carcinoma, renal rell carcinoma, epilepsy, hip fracture or osteo-arthritis of the knee.
- Written informed consent

Exlcusion NEW:
- Co-morbidities and neuromuscular disorders of the lower limbs severely interacting with mobility with limited or no opportunity for improvement (e.g. cerebral palsy);
- Peripheral arterial disease Fontaine III or IV;
- Chronic obstructive pulmonary disease (COPD) GOLD III or IV;
- Use of systemic steroids in the past four weeks, other than indicated for the specific type of surgery;
- Use anti-inflammatory biologicals (e.g. TNF-alfa blockers) in the past four weeks;
- Phenylketonuria (PKU);
- Surgical intervention in the past four weeks;
- Insulin dependent diabetes mellitus;
- Total parenteral nutrition at day of surgery;
- Pregnancy;
- Neoadjuvant chemo- or radiotherapy in the past four weeks;
- Organ-specific exclusion criteria (see below).
Organ specific exclusion criteria:
Heart:
- Medical history of ischemic heart disease
- heart failure
Kidney:
- Diabetes Mellitus
- GFR < 20 ml/min/1.73 m2
Bone:
- Life expectancy <6 months
- Time to surgery >48 hours.
Knee:
Use of injected corticosteroids in the replaced knee the past 3 months.
Use of bisphosphonates in the past 3 months.
Rheumatoid arthritis or other inflammatory joint diseases.
Knee surgery within the last 3 months.
Osteoarthritis of the knee secondary to septic arthritis, osteonecrosis, fracture, OD and tumor.
Collagen disorders, e.g. Marfan and Ehler-Danlos.
- RECORD23-apr-2015 - 12-mrt-2016


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