Autoimmune hyperthyroidism, Graves' disease, Graves'-Basedow's disease, Basedow disease, diffuse toxic goiter Graves' disease
Conditions
Interventions
Patients will be treated with monotherapy or block-and-replace therapy combined with a low or sufficient iodine diet.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:TRAb positive (>1,8).Decreased TSH (<0,7 mE/L).Increased FT4 (>22 pmol/L).Increased FT3 (>5,1 pmol/L). Should be able to give informed consent and have a normal life expectancy.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Being pregnant or breastfeeding.Having Graves’ ophthalmopathy at the start of the study.Having recurrent autoimmune hyperthyroidism (not being a newly diagnosed patient).Having undergone radioactive iodine treatment.Having undergone thyroidectomy.Using medication or other treatments containing iodine or influencing iodine status (such as Amiodarone).Undergoing or having undergone diagnostics with iodine-containing (contrast) agents.Using high doses of biotin (because of false-positive measurements of decreased TSH and elevated FT4 and FT3-levels), unless a person is willing to stop taking the dietary supplement biotin 24 hours before the start of the study due to sufficient time for elimination from the body.Having mechanical complaints due to a (large) goiter.Following a diet that affects the iodine status that cannot or should not be adjusted.Following an extremely high-protein diet such as ketogenic/low-carbohydrate because of the protein tyrosine, which, like iodine, is a raw material of thyroid hormone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is remission percentage 12 months after discontinuation of drug therapy based on monotherapy or block-and-replace therapy upon a low vs sufficient iodine diet. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are (change in) thyreostatics dosage, immunologic activity, quality-of-life, if patients whether or not develop Graves' ophthalmopathy, gut microbiome composition, lipid profile and GREAT+ prediction. | — |
Countries
Netherlands
Contacts
Public ContactERPC Wees-Jansen
Amsterdam UMC
Outcome results
None listed