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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2015
CompletedFirst Submitted
Initial submission to the registry
June 8, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2019
CompletedApril 19, 2019
April 1, 2019
3.2 years
June 8, 2017
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in nodule volume from baseline after metformin use
the impact of metformin on the volume of thyroid nodules
one year
Secondary Outcomes (2)
changes in nodule volume from baseline and changes in homa-ir
one year
changes in TSH levels from baseline after metformin use
one year
Study Arms (2)
Metformin
EXPERIMENTALpatients randomized to Metformin group
Placebo
PLACEBO COMPARATORpatients randomized to placebo group
Interventions
Eligibility Criteria
You may qualify if:
- patients with benign nodules diagnosed by fine needle aspiration biopsy (FNAB)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Patricia Santos
Rio de Janeiro, 21941913, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Santos, MD
UFRJ
- STUDY DIRECTOR
Patricia Teixeira, PhD
UFRJ
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 8, 2017
First Posted
June 12, 2017
Study Start
August 13, 2015
Primary Completion
October 17, 2018
Study Completion
April 17, 2019
Last Updated
April 19, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share