NCT03183752

Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

The Role of Insulin Resistance and the Effect of Metformin Use on Volume of Benign Thyroid Nodules

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hospital Universitário Clementino Fraga Filho · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Thyroid Nodule
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Metformin	500 mg metformin three times daily
DRUG	Placebo	500 mg placebo three times daily

Timeline

• Start date: 2015-08-13
• Primary completion: 2018-10-17
• Completion: 2019-04-17
• First posted: 2017-06-12
• Last updated: 2019-04-19

Locations

1 site across 1 country: Brazil