search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Metformin
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Thyroid Stage I focused on measuring differentiated thyroid cancer, THS suppression, metformin

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mashad University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

metformin

levothyroxine

Arm Description

patients who receive metformin in addition to levothyroxine

patients who receive only levothyroxine

Outcomes

Primary Outcome Measures

TSH

Secondary Outcome Measures

freeT3,freeT4

Full Information

First Posted
April 18, 2011
Last Updated
April 25, 2011
Sponsor
Mashhad University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01341886
Brief Title
Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Thyroid Stage I, Malignant Neoplasm of Thyroid Stage II
Keywords
differentiated thyroid cancer, THS suppression, metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metformin
Arm Type
Active Comparator
Arm Description
patients who receive metformin in addition to levothyroxine
Arm Title
levothyroxine
Arm Type
Placebo Comparator
Arm Description
patients who receive only levothyroxine
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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.
Primary Outcome Measure Information:
Title
TSH
Time Frame
3 months
Secondary Outcome Measure Information:
Title
freeT3,freeT4
Time Frame
3months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Mashad University of Medical Sciences
City
Mashad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs