- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03183752
Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules
The Role of Insulin Resistance and the Effect of Metformin Use on Volume of Benign Thyroid Nodules
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rio de Janeiro, Brazil, 21941913
- Patricia Santos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin
patients randomized to Metformin group
|
500 mg metformin three times daily
Other Names:
|
Placebo Comparator: Placebo
patients randomized to placebo group
|
500 mg placebo three times daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in nodule volume from baseline after metformin use
Time Frame: one year
|
the impact of metformin on the volume of thyroid nodules
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in nodule volume from baseline and changes in homa-ir
Time Frame: one year
|
the impact of insulin resistance in volume of thyroid nodules
|
one year
|
changes in TSH levels from baseline after metformin use
Time Frame: one year
|
the impact of metformin use in TSH levels
|
one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patricia Santos, MD, UFRJ
- Study Director: Patricia Teixeira, PhD, UFRJ
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRUPO RINT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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