Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules (NCT03183752) | Clinical Trial Compass
CompletedNot Applicable
Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules
Brazil28 participantsStarted 2015-08-13
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
changes in nodule volume from baseline after metformin use
Timeframe: one year
Trial details
NCT IDNCT03183752
SponsorHospital Universitário Clementino Fraga Filho