Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules
Primary Purpose
Thyroid Nodule, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule focused on measuring thyroid, insulin, thyroid nodule, insulin resistance, thyroid volume, metformin
Eligibility Criteria
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
Sites / Locations
- Patricia Santos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metformin
Placebo
Arm Description
patients randomized to Metformin group
patients randomized to placebo group
Outcomes
Primary Outcome Measures
changes in nodule volume from baseline after metformin use
the impact of metformin on the volume of thyroid nodules
Secondary Outcome Measures
changes in nodule volume from baseline and changes in homa-ir
the impact of insulin resistance in volume of thyroid nodules
changes in TSH levels from baseline after metformin use
the impact of metformin use in TSH levels
Full Information
NCT ID
NCT03183752
First Posted
June 8, 2017
Last Updated
April 17, 2019
Sponsor
Hospital Universitário Clementino Fraga Filho
1. Study Identification
Unique Protocol Identification Number
NCT03183752
Brief Title
Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules
Official Title
The Role of Insulin Resistance and the Effect of Metformin Use on Volume of Benign Thyroid Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 13, 2015 (undefined)
Primary Completion Date
October 17, 2018 (Actual)
Study Completion Date
April 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitário Clementino Fraga Filho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Insulin Resistance
Keywords
thyroid, insulin, thyroid nodule, insulin resistance, thyroid volume, metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized clinical trial with two groups: to use placebo or Metformine
Masking
ParticipantOutcomes Assessor
Masking Description
The same researcher blinded regarding location group will access thyroid volume and thyroid nodule volume by ultrasound, in the beginning, six months and one year after randomization
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Arm Description
patients randomized to Metformin group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients randomized to placebo group
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
MTF
Intervention Description
500 mg metformin three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLC
Intervention Description
500 mg placebo three times daily
Primary Outcome Measure Information:
Title
changes in nodule volume from baseline after metformin use
Description
the impact of metformin on the volume of thyroid nodules
Time Frame
one year
Secondary Outcome Measure Information:
Title
changes in nodule volume from baseline and changes in homa-ir
Description
the impact of insulin resistance in volume of thyroid nodules
Time Frame
one year
Title
changes in TSH levels from baseline after metformin use
Description
the impact of metformin use in TSH levels
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Santos, MD
Organizational Affiliation
UFRJ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Teixeira, PhD
Organizational Affiliation
UFRJ
Official's Role
Study Director
Facility Information:
Facility Name
Patricia Santos
City
Rio de Janeiro
ZIP/Postal Code
21941913
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules
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