autoimmune hypothyroidism Hashimoto's thyroiditis
Conditions
Interventions
3x 0.9mg Thyrogen injection intramuscular.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy controls: - Caucasian - 35 - 70 years - BMI 18 - 30 kg/m2 - Able to give informed consent SCT: - Caucasian - 35 - 70 years - BMI 18 - 30 kg/m2 - Able to give informed consent - Recent diagnosis of SCT: o TSH >= 10 mU/L, FT4 within normal range and anti-TPO positive
Exclusion criteria
Exclusion criteria: For all subjects: - Use of any medication including levothyroxine, proton pump inhibitors, antibiotics and pro-/ probiotics in the past three months - Diagnosis or symptoms of other autoimmune disease (e.g. T1D, coeliac, rheumatoid arthritis or inflammatory bowel disease like Crohn and colitis ulcerosa) - History of cholecystectomy - Smoking or illicit drug use (MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period - Pregnant or lactating women - Previous intestinal (e.g., bowel resection/reconstruction) surgery - Chronic illness (including a known history of heart failure, renal failure (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is difference in residual thyroid function (stimulated FT4 and FT3 response upon administration of 0.9 mg Thyrogen AUC0-48h) between SCT subjects and healthy controls. The AUC values will be derived according to the trapezoidal rule. AUC mean 0 - 48 hours denotes the AUC0-48h divided by the length of the time periode (i.e. 48h) and hence gives the mean level during the time period 0-48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in residual thyroid function (stimulated FT4 and FT3 response upon administration of 0.9 mg Thyrogen AUC0-48h) in SCT subjects and healthy controls after a short course of antibiotics. Thyroid hormone metabolism - Evaluate differences in thyroid hormone metabolism in SCT and healthy controls, using fecal excretion of T3 and T4. - Evaluate differences in thyroid hormone metabolism in SCT and healthy controls, using fecal excretion of T3 and T4 after thyroid stimulation test. - Evaluate the effect of the gut microbiome on thyroid metabolism in SCT vs healthy controls before and after ATB challenge before thyroid stimulation test. - Evaluate the effect of the gut microbiome on thyroid metabolism in SCT vs healthy controls before and after ATB challenge after thyroid stimulation test Other study parameters (if applicable) Inflammation Evaluate the effect of thyroid stimulation on the gut microbiome of SCT and healthy controls before, during and after short term antibiotics course on plasma inflammatory markers and FACS (evaluation criteria = changes in PBMC phenotype) Gut microbiome composition Change in relative abundance of bacteria taxa and bacterial gene richness by 16s rRNA profiling during several timepoints. Also, plasma metabolite composition will be determined. Finally intestinal transit time will be determined by Sitzmark Transit-Pellets. | — |
Countries
Netherlands
Outcome results
None listed