Insights into the pathophysiology of Hashimoto thyroiditis: Assessing thyroid Reserve capacity & the role of the Gut micrObiome in thyroid hormone metaboliSm

Completed

Conditions: Hashimoto's thyroiditis
10043739
autoimmune hypothyroidism

Registration Number: NL-OMON49953

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

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
<p>Primary endpoint is difference in residual thyroid function (stimulated FT4 and<br /><br>FT3 response upon administration of 0.9 mg Thyrogen AUC0-48h) between SCT<br /><br>subjects and healthy controls. The AUC values will be derived according to the<br /><br>trapezoidal rule. AUC mean 0 - 48 hours denotes the AUC0-48h divided by the<br /><br>length of the time periode (i.e. 48h) and hence gives the mean level during the<br /><br>time period 0-48 hours. </p><br>

Secondary Outcome Measures