Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183752
• Other study ID #: GRUPO RINT
• Status: Completed
• Phase: N/A
• Start date: August 13, 2015
• Est. completion date: April 17, 2019

Study information

• Verified date: April 2019
• Source: Hospital Universitário Clementino Fraga Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 17, 2019
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Thyroid Diseases
• Thyroid Nodule

Intervention

Drug:
• Metformin
500 mg metformin three times daily
• Placebo
500 mg placebo three times daily

Locations

Country	Name	City	State
Brazil	Patricia Santos	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitário Clementino Fraga Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in nodule volume from baseline after metformin use	the impact of metformin on the volume of thyroid nodules	one year
Secondary	changes in nodule volume from baseline and changes in homa-ir	the impact of insulin resistance in volume of thyroid nodules	one year
Secondary	changes in TSH levels from baseline after metformin use	the impact of metformin use in TSH levels	one year