Patricia Santos
Rio de Janeiro, 21941913, Brazil
NCT Number: NCT03183752
It has been shown that insulin might be involved in the pathogenesis of thyroid growth.
Objective To evaluate the impact of IR and metformin use on the volume of benign thyroid nodules (TNs).
Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle aspiration confirming the diagnosis is necessary to inclusion. Patients will receive similar tablets of MTF and placebo and instruct to take 3 tablets/day of MTF (500mg/tablet). Thyroid volume, as TN volume, will be assess by ultrasound, both in the beginning, six months and one year after randomization, by the same researcher blinded regarding location group. Blood samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h fasting.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Rio de Janeiro, 21941913, Brazil
It has been shown that insulin might be involved in the pathogenesis of thyroid growth. Previous studies suggest that metformin (MTF) therapy decreased thyroid volume and nodule size in subjects with insulin resistance (IR).
Objectives To evaluate the impact of IR and metformin use on the volume of benign thyroid nodules (TNs).
Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle aspiration confirming the diagnosis is necessary to inclusion. Exclusion criteria were: nodules with a predominantly cystic pattern, pregnancy, diabetes, acromegaly, previous use of MTF, levothyroxine, corticoid or any weight loss medication in the past six months, hepatic or cardiac insufficiency, creatinine levels > 1.4 mg/dL and MTF intolerance doses >1.0 gram/day. Patients will receive similar tablets of MTF and placebo and will be instructed to take 3 tablets/day of MTF (500mg/tablet). Thyroid volume, as TN volume, will be accessed by ultrasound, both in the beginning, six months and one year after randomization, by the same researcher blinded regarding location group. Blood samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h fasting.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500 mg metformin three times daily
Other names: MTF
500 mg placebo three times daily
Other names: PLC
Time frame: one year
the impact of metformin on the volume of thyroid nodules
Time frame: one year
the impact of insulin resistance in volume of thyroid nodules
Time frame: one year
the impact of metformin use in TSH levels
Hospital Universitário Clementino Fraga Filho
Other
The Role of Insulin Resistance and the Effect of Metformin Use on Volume of Benign Thyroid Nodules
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