Age dependent effects of thyroid hormones - search for new biomarkers
- Conditions
- Experimental thyrotoxicosishealthy volunteers
- Registration Number
- DRKS00013327
- Lead Sponsor
- Exp. und Klin. Endokrinologie, Med. Klinik I UKSH, Campus Lübeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Healthy subjects 18 – 40 years of age as well as > 60 years – BMI 20 to 30 kg/m2 – written consent
Participation in other studies either parallel or during the last 4 weeks
Known disease of the thyroid
Any disease of the gastrointestinal tract associated with an unclear partial or total drug resorption like complete or partial gastrectomy, inflammatory bowel disease, lactose intolerance, chronic diarrhoea)
Any neurological (e.g. Parkinson’s disease, multiple sclerosis, stroke, brain injury) or psychiatric disorder (e.g. depression, schizophrenia)
Medically not fully compensated cardiovascular or respiratory diseases
Severe kidney or liver disorders
Other severer internal disorders (e.g. diabetes mellitus, anemia, vitamin deficiencies, malignant diseases, AIDS)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method new biomarker New biomarkers will be analyzed by metabolomics (Biocrates Absolute IDQ™-kit p180, Biocrates Life Sciences AG, Innsbruck, Austria), proteomics following digestion of abundant proteins by proteases like trypsin and elimination using MARS-6 followed by analysis using nHPLC-LC-MS/MS with OrbiTrap-Velos/ Q-Exactive hybrid mass spectromety. Intensity-based quantification following identification using Rosetta Elucidator and N M-Refiner/ MS-Analyst (GenData Inc.). For analysis of the transkriptome whole blood will be investigated using microarray-based expression analysis (lllumina Human HT-12 v4 Expression BeadChips).<br>Investigations are made at the following time points: - 30 min, 0 min, 1 h, 2 h, 4 h, 24 h, 48 h und 72 h.
- Secondary Outcome Measures
Name Time Method To test the influence of thyroxine or as control calciumascorbate we compare both conditions 72 h following each ingestion by the effect on a standardized breakfast, on specific questionnaires and on fMRI changes when the volunteers are stimulated by food and control non-food images