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Completed

NCT Number: NCT03183752

Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patricia Santos

Rio de Janeiro, 21941913, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with benign nodules diagnosed by fine needle aspiration biopsy (FNAB)

Exclusion criteria

  • Nodules with a predominantly cystic pattern
  • Eggshell calcification
  • Coalescent thyroid nodules (not suitable for size analysis)
  • 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
  • MTF intolerance doses < 1.0 gram/day

Treatment and study plan

metformin

Drug

500 mg metformin three times daily

Other names: MTF

Placebo

Drug

500 mg placebo three times daily

Other names: PLC

Primary outcomes

  1. changes in nodule volume from baseline after metformin use

    Time frame: one year

    the impact of metformin on the volume of thyroid nodules

Secondary outcomes

  1. changes in nodule volume from baseline and changes in homa-ir

    Time frame: one year

    the impact of insulin resistance in volume of thyroid nodules

  2. changes in TSH levels from baseline after metformin use

    Time frame: one year

    the impact of metformin use in TSH levels

Sponsors and collaborators

Lead sponsor

Hospital Universitário Clementino Fraga Filho

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 12, 2017
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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