Release of X-Pro dipeptides and amino acids from stable isotope-labelled gluten-related immunogenic peptided by AMY01
- Conditions
- Physiological study
- Registration Number
- DRKS00033108
- Lead Sponsor
- niversitätsmedizin Greifswald
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 16
understands the study purpose and design
- contractually capable and provides signed informed consent form
- healthy condition or mild and/or well treated forms of allergies, asthma,
hypertension, and orthopedic diseases
a.BMI > 35 kg/m2 and <18 kg/m2
b.known pregnancy or lactation period
c.women: positive urine pregnancy test at screening or visit
d.anemia (Hb < 13 g/dl (8,07 mmol/l) in men or < 12 g/dl (7,45 mmol/l)
in women
e.blood donation within the last 4 weeks
f.elevated liver function tests (ALAT, ASAT, yGT, Bilirubin > 2x ULN)
g.reduced renal function (eGFR MDRD < 60 ml/min/1,7m2)
h.known history of celiac disease or gluten intolerance
i.known gastrointestinal disease
j.intake of proton pump inhibitors
k.prescription of > 2 drugs taken during the screening and study visits
period
l.psychiatric disease or drug dependency
m.use of recreational drugs more than twice a week
n.poor venous conditions that make it impossible to place a peripheral
venous catheter and regularly draw blood through it
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the occurrence of labelled dipeptides and labelled amino acids in blood and urine samples. We are testing two hypotheses:<br>1.labelled 33-mer + AMY01<br> significant amounts of dipeptides and amino acids are detectable<br>2.labelled 33-mer alone<br> dipeptides and amino acids are detectable in lower amounts if at all
- Secondary Outcome Measures
Name Time Method - AUC0-10h for each labelled dipeptide and amino acid<br>- Tmax of each labelled dipeptide and amino acid<br>- Cmax of each labelled dipeptide and amino acid<br>- renal clearance of each labelled dipeptide and amino acid