Thyroid NoduleNCT03183752
Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules
A study testing Metformin in people with Thyroid Nodule and Insulin Resistance, run by Hospital Universitário Clementino Fraga Filho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule, Insulin Resistance
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Aug 2015to 17 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with benign nodules diagnosed by fine needle aspiration biopsy (FNAB)
Who cannot join
- Nodules with a predominantly cystic pattern
- Eggshell calcification
- Coalescent thyroid nodules (not suitable for size analysis)
- Pregnancy
- Diabetes
- Acromegaly
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Nodule, Insulin Resistance
- Being tested
- Metformin, Placebo
- Keywords
- thyroid, insulin, thyroid nodule, insulin resistance, thyroid volume, metformin
- Medical subject headings
- Thyroid Nodule, Insulin Resistance, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called MTF
500 mg metformin three times daily
PlaceboDrug
Also called PLC
500 mg placebo three times daily
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | patients randomized to Metformin group Receives: Drug: Metformin |
| Placebo | Placebo comparator | patients randomized to placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in nodule volume from baseline after metformin use
the impact of metformin on the volume of thyroid nodules
Measured: one year
Secondary outcomes (2)
changes in nodule volume from baseline and changes in homa-ir
the impact of insulin resistance in volume of thyroid nodules
Measured: one year
changes in TSH levels from baseline after metformin use
the impact of metformin use in TSH levels
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start13 Aug 2015
- Primary completion17 Oct 2018
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical trial with two groups: to use placebo or Metformine
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Clementino Fraga Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Borges dos Santos, Hospital Universitário Clementino Fraga Filho
- Investigators
- Patricia Santos, MD, Principal investigator, UFRJPatricia Teixeira, PhD, Study director, UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183752
- Sponsor's protocol ID
- GRUPO RINT
- Status last verified
- Apr 2019
- First submitted
- 8 Jun 2017
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Insulin Resistance and the Effect of Metformin Use on Volume of Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT03183752
- Acronym / sponsor ID
- GRUPO RINT
- Conditions
- Thyroid Nodule, Insulin Resistance
- Keywords
- thyroid, insulin, thyroid nodule, insulin resistance, thyroid volume, metformin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital Universitário Clementino Fraga FilhoUniversity, hospital or other
- Study start
- 13 Aug 2015
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized clinical trial with two groups: to use placebo or Metformine
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metforminpatients randomized to Metformin group |
| Placebo | Placebo comparator | Drug: Placebopatients randomized to placebo group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with benign nodules diagnosed by fine needle aspiration biopsy (FNAB)
Key exclusion criteria (10 listed)
- Nodules with a predominantly cystic pattern
- Eggshell calcification
- Coalescent thyroid nodules (not suitable for size analysis)
- Pregnancy
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: MTF500 mg metformin three times daily | Drug | Metformin |
| PlaceboAlso: PLC500 mg placebo three times daily | Drug | Placebo |
Primary outcome
changes in nodule volume from baseline after metformin use
Time frame: one year
the impact of metformin on the volume of thyroid nodules
2 secondary outcomes
changes in nodule volume from baseline and changes in homa-ir
Time frame: one year
changes in TSH levels from baseline after metformin use
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Santos, MD principal investigator
UFRJ
Patricia Teixeira, PhD study director
UFRJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Thyroid Nodule and Insulin Resistance, run by Hospital Universitário Clementino Fraga Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in nodule volume from baseline after metformin use (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.