Experimental thyrotoxicosis healthy volunteers
Conditions
Interventions
Group 1: l-thyroxine 1 mg once p.o.
Measurement of TSH, fT4 and fT3 as well as biomarkers
Group 2: calcium ascorbate 300 mg once p.o. with measurement of TSH, fT4 and fT3 as well as biomarkers
Sponsors
Exp. und Klin. Endokrinologie, Med. Klinik I UKSH, Campus Lübeck
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Healthy subjects 18 – 40 years of age as well as > 60 years – BMI 20 to 30 kg/m2 – written consent
Exclusion criteria
Exclusion criteria: Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactGeorg Brabant
Exp. und Klin. Endokrinologie, Med. Klinik I UKSH, Campus Lübeck
Outcome results
None listed