Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

NCT03183752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-04-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Metformin

500 mg metformin three times daily

DRUG

Placebo

500 mg placebo three times daily

Sponsors & Collaborators

  • Hospital Universitário Clementino Fraga Filho

    lead OTHER

Principal Investigators

  • Patricia Santos, MD · UFRJ

  • Patricia Teixeira, PhD · UFRJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-13
Primary Completion
2018-10-17
Completion
2019-04-17

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03183752 on ClinicalTrials.gov