Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer

NCT ID: NCT01341886

Last Updated: 2011-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-04-30

Brief Summary

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Differentiated thyroid cancer is the most common neoplasm of endocrine system. After surgery and radioiodine treatment, thyroid stimulating hormone (TSH) suppression is the main goal which is achieved with levothyroxine treatment. Levothyroxine causes increased thyroid hormones which can have negative impact on bone and cardiovascular system. Anecdotal reports have shown that metformin can induce TSH suppression without change in T3 and T4 concentration. The purpose of this study was to prescribe metformin as additional drug to levothyroxin in order to decrease levothyroxine dosage.

Detailed Description

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Conditions

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Malignant Neoplasm of Thyroid Stage I Malignant Neoplasm of Thyroid Stage II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin

patients who receive metformin in addition to levothyroxine

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

in case group metformin is added to levothyroxine and levothyroxine is decreased by 30% .in control group levothyroxine is reduced by 30% and no metformin is added to the regimen.

levothyroxine

patients who receive only levothyroxine

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type DRUG

in case group metformin is added to levothyroxine and levothyroxine is decreased by 30% .in control group levothyroxine is reduced by 30% and no metformin is added to the regimen.

Interventions

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Metformin

in case group metformin is added to levothyroxine and levothyroxine is decreased by 30% .in control group levothyroxine is reduced by 30% and no metformin is added to the regimen.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* papillary or follicular thyroid cancer
* stage 1 or 2 according to TNM system version 6
* surgery and radioiodine treatment
* levothyroxine suppression treatment

Exclusion Criteria

* cardiopulmonary failure
* liver failure
* renal failure
* pregnancy
* drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin)
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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endocrine research center

Locations

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Mashad University of Medical Sciences

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Other Identifiers

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METTC

Identifier Type: -

Identifier Source: org_study_id

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