Diabetes Mellitus, Type 2Phase 4NCT00463502
The Effect of Metformin Treatment on Thyroid Hormone Metabolism in Euthyroid Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Metformin in people with Diabetes Mellitus, Type 2, run by Haydarpasa Numune State Hospital.
Trial summary
Aim: To investigate the effects of metformin treatment on thyroid hormone metabolism in euthyroid patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 35 to 78 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 78 years
- All sexes
- Adult, Older adult
Who may be able to join
- The patients included in this study were the ones who were newly diagnosed with type 2 diabetes mellitus
Who cannot join
- Presence of thyroid disorders, positive thyroid autoantibodies and usage of medications affecting thyroid hormones such as amiodarone, lithium were accepted as exclusion criterions
About this study
Aim: To investigate the effects of metformin treatment on thyroid hormone metabolism in euthyroid patients with type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Metformin
- Keywords
- The purpose of study was investigated the effect of, metformin on thyroid hormone metabolism in euthyroid patients, with type 2 DM. The results revealed significant decreases, in TSH and fT4
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune State Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ali Ozdemir, Principal investigator, Unaffiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463502
- Sponsor's protocol ID
- 07-013
- Status last verified
- Mar 2007
- First submitted
- 19 Apr 2007
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin Treatment on Thyroid Hormone Metabolism in Euthyroid Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00463502
- Acronym / sponsor ID
- 07-013
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- The purpose of study was investigated the effect of, metformin on thyroid hormone metabolism in euthyroid patients, with type 2 DM. The results revealed significant decreases, in TSH and fT4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Haydarpasa Numune State HospitalUniversity, hospital or other
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To investigate the effects of metformin treatment on thyroid hormone metabolism in euthyroid patients with type 2 diabetes mellitus.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 78 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients included in this study were the ones who were newly diagnosed with type 2 diabetes mellitus
Key exclusion criteria (1 listed)
- Presence of thyroid disorders, positive thyroid autoantibodies and usage of medications affecting thyroid hormones such as amiodarone, lithium were accepted as exclusion criterions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Ozdemir principal investigator
Unaffiliation
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Diabetes Mellitus, Type 2, run by Haydarpasa Numune State Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.