Type 2 Diabetes MellitusNCT01963663
Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients
A study testing Metformin and Pioglitazone in people with Type 2 Diabetes Mellitus, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIran
- Study dates
- Nov 2012to Apr 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes
Who cannot join
- positive history for taking anti-diabetes medications of any class in the past
- positive current history for taking over-the-counter vitamin or anti-oxidant supplements
- presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences
Tehran, Tehran Province, 13145-784
About this study
Official title: Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes
Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin, Pioglitazone
- Keywords
- YKL-40, Chronic low grade inflammation, type 2 diabetes mellitus, metformin, pioglitazone
- 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
metformin 1000 mg daily in two divided doses of 500 mg tablets
PioglitazoneDrug
pioglitazone 30 mg daily in two divided doses of 15 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | patients receiving fixed dose metformin 1000 mg daily Receives: Drug: Metformin |
| Pioglitazone | Active comparator | patients receiving fixed dose pioglitazone 30 mg daily Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of YKL-40
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Esteghamati, Tehran University of Medical Sciences
- Investigators
- Alireza Esteghamati, M.D., Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963663
- Sponsor's protocol ID
- 92/d/130/499
- Status last verified
- Oct 2013
- First submitted
- 13 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Esteghamati A, Azizi R, Ebadi M, Noshad S, Mousavizadeh M, Afarideh M, Nakhjavani M. The comparative effect of pioglitazone and metformin on serum osteoprotegerin, adiponectin and intercellular adhesion molecule concentrations in patients with newly diagnosed type 2 diabetes: a randomized clinical trial. Exp Clin Endocrinol Diabetes. 2015 May;123(5):289-95. doi: 10.1055/s-0034-1396864. Epub 2015 Jan 21.
PubMed 25607338
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01963663
- Acronym / sponsor ID
- 92/d/130/499
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- YKL-40, Chronic low grade inflammation, type 2 diabetes mellitus, metformin, pioglitazone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Oct 2013 (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.
Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metforminpatients receiving fixed dose metformin 1000 mg daily |
| Pioglitazone | Active comparator | Drug: Pioglitazonepatients receiving fixed dose pioglitazone 30 mg daily |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes
Key exclusion criteria (3 listed)
- positive history for taking anti-diabetes medications of any class in the past
- positive current history for taking over-the-counter vitamin or anti-oxidant supplements
- presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.
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 |
|---|---|---|
| Metforminmetformin 1000 mg daily in two divided doses of 500 mg tablets | Drug | Metformin |
| Pioglitazonepioglitazone 30 mg daily in two divided doses of 15 mg tablets | Drug | Pioglitazone |
Primary outcome
Serum concentration of YKL-40
Time frame: 12 weeks
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 16 Oct 2013.
- Derived from this study: PubMed 25607338Esteghamati A, Azizi R, Ebadi M, Noshad S, Mousavizadeh M, Afarideh M, Nakhjavani M. The comparative effect of pioglitazone and metformin on serum osteoprotegerin, adiponectin and intercellular adhesion molecule concentrations in patients with newly diagnosed type 2 diabetes: a randomized clinical trial. Exp Clin Endocrinol Diabetes. 2015 May;123(5):289-95. doi: 10.1055/s-0034-1396864. Epub 2015 Jan 21.
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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.
Alireza Esteghamati, M.D. principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Pioglitazone in people with Type 2 Diabetes Mellitus, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 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 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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.
What does the primary outcome measure?
Serum concentration of YKL-40 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963663, which also lists 1 linked publication.
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 16 Oct 2013.