NCT01341886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

April 18, 2011

Last Update Submit

April 25, 2011

Conditions

Malignant Neoplasm of Thyroid Stage IMalignant Neoplasm of Thyroid Stage II

Keywords

differentiated thyroid cancerTHS suppressionmetformin

Outcome Measures

Primary Outcomes (1)

  • TSH

    3 months

Secondary Outcomes (1)

  • freeT3,freeT4

    3months

Study Arms (2)

metformin

ACTIVE COMPARATOR

patients who receive metformin in addition to levothyroxine

Drug: Metformin

levothyroxine

PLACEBO COMPARATOR

patients who receive only levothyroxine

Drug: Metformin

Interventions

MetforminDRUG

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.

levothyroxinemetformin

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashad University of Medical Sciences

Mashhad, Khorasan Razavi, Iran

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 26, 2011

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 26, 2011

Record last verified: 2011-04

Locations

IR(1)