A mono-center, non-interventional pilot study of sample quality measured by PESI-MS after delayed centrifugatio
- Conditions
- healthy or diverse
- Registration Number
- DRKS00024807
- Lead Sponsor
- CBmed GmbH - Center for Biomarker Research in Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Subject Inclusion Criteria heterogeneous group
1.Signed informed consent before any trial-related activities
2.Male or female or transgender (any)
3.Age between 18 – 90 years (both inclusive)
4.Body mass index (BMI) above = 18.5 kg/m2
5.With at least one of any metabolism impacting specialty or medical condition such as (but not limited to):
oNon-standard diet (e.g. vegan, raw, Atkins low carbohydrate, intermittent fasting, ketogenic…)
oNon-Caucasian ethnicity
oAge outside the range of homogenous group (outside 20-30)
oChronic metabolic disease (e.g. Diabetes, obesity)
oChronic autoimmune disease (e.g. systemic lupus erythema, rheumatoid diseases, multiple sclerosis)
oChronic lung disease (e.g. pulmonary hypertension, chronic obstructive lung disease)
oPartial or total removal of organs (e.g. Hysterectomy, kidney donation, bariatric surgery) or transplant receiver
oSubstance abuse (e.g. alcohol, drug of abuse, smoking)
oDigestive diseases or malabsorption necessitating specific diet (e.g. glu-ten-free, fructose-free, Morbus Crohn, Phenylketonuria)
oConcomitant medication (e.g. heparin, nonsteroidal or steroidal anti-inflammatory drugs, corticosteroids, growth hormones, antihistamines or selective serotonin reuptake inhibitors)
oWomen in midst of their menopause
oAcute disease (e.g. common cold, light fever, recuperating from a bone fracture or surgery)
oHormonal contraception (e.g. oral, coil, Implanon, 3 month injection)
oAs judged by the investigator and accordingly noted in the SDF
Gender distribution within the group should be approximately balanced, i.e. each should be between 40-60% of total group size: 12-18 female, 12-18 male.
Subject Inclusion Criteria homogeneous group
1.Signed informed consent before any trial-related activities
2.Male or female
3.Age between 20 – 30 years (both inclusive)
4.Body mass index (BMI) between18.5 – 25 kg/m2(both inclusive)
5.Ethnicity Caucasian
6.Drug of abuse abstinent (for >1 year pre-trial)
7.Non-smoker or light smoker (=1 cigarette/week)
8.Abstinent or only light alcohol consumption (=7 units/week, 1 unit = 10 ml or 8 g alcohol)
Subject Exclusion Criteria heterogeneous group
1.Severe acute, or severe chronic diseases or any other condition which at the investigator’s judgement would interfere with the safety of the subject or with the study results
2.Known anaemia, blood or plasma donation within the last month
3.Pregnancy, breastfeeding, intention of becoming pregnant or not using ade-quate contraception
4.Mental incapacity, unwillingness or language barriers precluding adequate un-derstanding or co-operation
Subject Exclusion Criteria homogeneous group
1.Any acute or chronic diseases or any other condition which at the investigator’s judgement would interfere with the safety of the subject or with the study results
2.Known anaemia, blood or plasma donation within the last month
3.Pregnancy, breastfeeding, intention of becoming pregnant or not using ade-quate contraception
4.Hormonal contraception (e.g. oral, coil, Implanon, 3 month injection)
5.Intake of medication with heparin, nonsteroidal or steroidal anti-inflammatory drugs within the last 10 days, and medication with antihistamines or selective serotonin reuptake inhibitors within the last 4 weeks, in vitro fertilization (IVF) treatment in the last 3 months
6.Surgery within the last 3 months
7.Non-standard diet (e.g. vegan, vegetarian, gluten-free, malabsorption specific diets, atkins, raw, intermittent-fasting, ketogenic…)
8.Mental incapacity, unwillingness or language barriers precluding adequate un-derstanding or co-operation
Gender distribution within the group should be approximately balanced, i.e. each should be between 40-60% of total group size: 8-12 female, 8-12 male.
8.62nd Study Visit – Exclusion Criteria only for homogenous group
1.Any acute or chronic diseases or any other condition which at the investigator’s judgement would interfere with the safety of the subject or with the study results
2.No overnight fast (12 h, last meal 18:00 of the previous day)
3.Intensive physical activity (>30 min with pulse >120 or sweating for >15 min) in the last 24 h
4.Consumed alcohol/smoking in the last 24 h
5.Result of alcohol breath test = 0 ‰
6.Consumed drugs of abuse since 1st Visit
7.Intake of any medication since 1st Visit
8.Abnormal body temperature (outside of 35.9–37.6°C)
Subjects not compliant with the instructions for the 2nd visit (fasting, abstinence) can be rescheduled within up to three weeks if compliance is foreseeable, possible and likely. Subjects excluded from the homogenous group according to criteria which are unlikely to be compliant even after a reschedule can be reassigned to the heterogeneous group if compliant to those in-/exclusion criteria.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In order to achieve the primary objective, PESI-MS spectral differences from optimally handled samples vs. samples with delayed centrifugation will be obtained by means of single peak and full spectra (fingerprint) ap-proaches. The performance of sample quality biomarkers or biomarker pattern based on these spectral differences will be tested. Reliable detec-tion of a delay of =3 h versus immediate centrifugation of blood samples for plasma preparation is defined here as achieving an area under the curve (AUC) =0.85 in a receiver operator characteristic (ROC).
- Secondary Outcome Measures
Name Time Method