NCT03183752

Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

Completed NA Last updated 19 April 2019

What this trial tests

NA trial testing Metformin in Thyroid Nodule in 28 participants. Completed in 17 April 2019.

Timeline

13 August 2015

Primary endpoint
17 October 2018

17 April 2019

Quick facts

Lead sponsor	Hospital Universitário Clementino Fraga Filho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	28
Start date	13 August 2015
Primary completion	17 October 2018
Estimated completion	17 April 2019
Sites	1 location across Brazil

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• Placebo

Conditions studied

• Thyroid Nodule — all drugs for Thyroid Nodule →
• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

Hospital Universitário Clementino Fraga Filho

Who can join

Adults 18 to 80, any sex, with Thyroid Nodule or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of an anti-diabetic drug metformin in the treatment of endocrine tumors.
   Thakur S, Daley B, Klubo-Gwiezdzinska J. · · 2019 · cited 45× · PMID 31307011 · DOI 10.1530/jme-19-0083
2. Metformin as a promising target for DPP4 expression: computational modeling and experimental validation.
   El-Arabey AA, Zhang H, Abdalla M, Al-Shouli ST, et al · · 2023 · cited 8× · PMID 37624423 · DOI 10.1007/s12032-023-02140-4
3. Effects of Metformin on TSH Levels and Benign Nodular Goiter Volume in Patients Without Insulin Resistance or Iodine Insufficiency.
   Dos Santos PB, Gertrudes LN, Conceição FL, de Andrade BM, et al · · 2019 · cited 8× · PMID 31379740 · DOI 10.3389/fendo.2019.00465