Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

Not Applicable

Completed

• Conditions: Thyroid Nodule; Insulin Resistance
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT03183752
• Lead Sponsor: Hospital Universitário Clementino Fraga Filho

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08-13
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Primary Completion: 2018-10-17
• Status Verified: 2019-04
• Study Completion: 2019-04-17
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	patients randomized to placebo group
Metformin	Metformin	patients randomized to Metformin group

Primary Outcome Measures

Name	Time	Method
changes in nodule volume from baseline after metformin use	one year	the impact of metformin on the volume of thyroid nodules

Secondary Outcome Measures

Name	Time	Method
changes in nodule volume from baseline and changes in homa-ir	one year	the impact of insulin resistance in volume of thyroid nodules
changes in TSH levels from baseline after metformin use	one year	the impact of metformin use in TSH levels

Trial Locations

Locations (1)

Patricia Santos; 🇧🇷 Rio de Janeiro, Brazil