Insights into the pathophysiology of HAshimoto’s Thyroiditis: Assessing Residual thyroid cApacity & the role of the gut Microbiome in thyroid hormone metabolism

Recruiting

Conditions: subclinical hypothyroidism

Registration Number: NL-OMON22728

Lead Sponsor: Amsterdam UMC

Brief Summary: will follow

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Healthy controls:
-Caucasian
-35 – 70 years
-BMI 18 – 30 kg/m2
-Able to give informed consent

subclinical hypothyroidism:
-Caucasian
-35 – 70 years
-BMI 18 – 30 kg/m2
-Able to give informed consent
-Recent diagnosis of subclinical hypothyroidism: TSH = 10 mU/L, FT4 within normal range and anti-TPO positive

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 <30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the difference in thyroid gland secretion capacity by measuring maximal FT4 and FT3 response upon intramuscular administration of 0.9mg Thyrogen assessed by AUC0-48hours in subclinical hypothyroid subjects and healthy controls after thyroid stimulation and before and after a short term antibiotics course.

Secondary Outcome Measures