Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer
Overview[ - collapse ][ - ]
| Purpose | 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 | Malignant Neoplasm of Thyroid Stage I Malignant Neoplasm of Thyroid Stage II |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Mashhad University of Medical Sciences |
| Responsible Party | Mashhad University of Medical Sciences |
| ClinicalTrials.gov Identifier | NCT01341886 |
| First Received | April 18, 2011 |
| Last Updated | April 25, 2011 |
| Last verified | April 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 18, 2011 |
|---|---|
| Last Updated Date | April 25, 2011 |
| Start Date | April 2010 |
| Estimated Primary Completion Date | April 2011 |
| Current Primary Outcome Measures | TSH [Time Frame: 3 months] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | freeT3,freeT4 [Time Frame: 3months] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer |
|---|---|
| Official Title | Not Provided |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| 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. |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 51 |
| Estimated Completion Date | April 2011 |
| Estimated Primary Completion Date | April 2011 |
| 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) |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Iran, Islamic Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01341886 |
|---|---|
| Other Study ID Numbers | METTC |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Mashhad University of Medical Sciences |
| Study Sponsor | Mashhad University of Medical Sciences |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | April 2011 |
Locations[ + expand ][ + ]
| Mashad University of Medical Sciences | Mashad, Khorasan Razavi, Iran, Islamic Republic of |
|---|