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Trial record 24 of 667 for:    Recruiting, Not yet recruiting, Available Studies | "Insulins"

Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT03183752
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Patricia Borges dos Santos, Hospital Universitário Clementino Fraga Filho

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.


Condition or disease Intervention/treatment Phase
Thyroid Nodule Insulin Resistance Drug: Metformin Drug: Placebo Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized clinical trial with two groups: to use placebo or Metformine
Masking: Double (Participant, Outcomes 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
Primary Purpose: Treatment
Official Title: The Role of Insulin Resistance and the Effect of Metformin Use on Volume of Benign Thyroid Nodules
Study Start Date : August 13, 2015
Estimated Primary Completion Date : July 10, 2018
Estimated Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Experimental: Metformin
patients randomized to Metformin group
Drug: Metformin
500 mg metformin three times daily
Other Name: MTF

Placebo Comparator: Placebo
patients randomized to placebo group
Drug: Placebo
500 mg placebo three times daily
Other Name: PLC




Primary Outcome Measures :
  1. changes in nodule volume from baseline after metformin use [ Time Frame: one year ]
    the impact of metformin on the volume of thyroid nodules


Secondary Outcome Measures :
  1. 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

  2. changes in TSH levels from baseline after metformin use [ Time Frame: one year ]
    the impact of metformin use in TSH levels



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183752


Contacts
Contact: Patricia Santos, MD 55 21 981669799 patriciaborges.endocrino@gmail.com

Locations
Brazil
Patricia Santos Recruiting
Rio de Janeiro, Brazil, 21941913
Contact: Patricia Santos    55 21 981669799    patriciaborges.endocrino@gmail.com   
Sponsors and Collaborators
Hospital Universitário Clementino Fraga Filho
Investigators
Principal Investigator: Patricia Santos, MD UFRJ
Study Director: Patricia Teixeira, PhD UFRJ

Responsible Party: Patricia Borges dos Santos, Principal Investigator, Hospital Universitário Clementino Fraga Filho
ClinicalTrials.gov Identifier: NCT03183752     History of Changes
Other Study ID Numbers: GRUPO RINT
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patricia Borges dos Santos, Hospital Universitário Clementino Fraga Filho:
thyroid
insulin
thyroid nodule
insulin resistance
thyroid volume
metformin

Additional relevant MeSH terms:
Insulin Resistance
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Insulin, Globin Zinc
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs