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

Malignant Neoplasm of Thyroid Stage I Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341886
• Other study ID #: METTC
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: April 25, 2011
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Neoplasm of Thyroid Stage I
• Malignant Neoplasm of Thyroid Stage II
• Neoplasms
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashad University of Medical Sciences	Mashad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TSH		3 months	Yes
Secondary	freeT3,freeT4		3months	Yes