Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

April 17, 2019 updated by: Patricia Borges dos Santos, Hospital Universitário Clementino Fraga Filho

The Role of Insulin Resistance and the Effect of 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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rio de Janeiro, Brazil, 21941913
        • Patricia Santos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
patients randomized to Metformin group
500 mg metformin three times daily
Other Names:
  • MTF
Placebo Comparator: Placebo
patients randomized to placebo group
500 mg placebo three times daily
Other Names:
  • PLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in nodule volume from baseline after metformin use
Time Frame: one year
the impact of metformin on the volume of thyroid nodules
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year
changes in TSH levels from baseline after metformin use
Time Frame: one year
the impact of metformin use in TSH levels
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patricia Santos, MD, UFRJ
  • Study Director: Patricia Teixeira, PhD, UFRJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 13, 2015

Primary Completion (Actual)

October 17, 2018

Study Completion (Actual)

April 17, 2019

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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