Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules
NCT ID: NCT03183752
Last Updated: 2019-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2015-08-13
2019-04-17
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Metformin
patients randomized to Metformin group
Metformin
500 mg metformin three times daily
Placebo
patients randomized to placebo group
Placebo
500 mg placebo three times daily
Interventions
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Metformin
500 mg metformin three times daily
Placebo
500 mg placebo three times daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Hospital Universitário Clementino Fraga Filho
OTHER
Responsible Party
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Patricia Borges dos Santos
Principal Investigator
Principal Investigators
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Patricia Santos, MD
Role: PRINCIPAL_INVESTIGATOR
UFRJ
Patricia Teixeira, PhD
Role: STUDY_DIRECTOR
UFRJ
Locations
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Patricia Santos
Rio de Janeiro, , Brazil
Countries
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Other Identifiers
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GRUPO RINT
Identifier Type: -
Identifier Source: org_study_id
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