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

• Sponsor: Mashhad University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01341886
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Neoplasm of Thyroid Stage I; Malignant Neoplasm of Thyroid Stage II	Drug: Metformin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: metformin patients who receive metformin in addition to levothyroxine	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.
Placebo Comparator: levothyroxine patients who receive only levothyroxine	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.

Outcome Measures

Primary Outcome Measures

1. TSH [3 months]

Secondary Outcome Measures

1. freeT3,freeT4 [3months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mashad University of Medical Sciences	Mashad	Khorasan Razavi	Iran, Islamic Republic of

Sponsors and Collaborators

• Mashhad University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01341886
• Other Study ID Numbers: METTC
• First Posted: Apr 26, 2011
• Last Update Posted: Apr 26, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: differentiated thyroid cancer; THS suppression; metformin
• Additional relevant MeSH terms: Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Metformin

Study Results

No Results Posted as of Apr 26, 2011