Type II Diabetes MellitusPhase 4NCT00306176
Rosiglitazone and Exercise in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Rosiglitazone in people with Type II Diabetes Mellitus, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of the present study is to investigate the influence of systemic exercise, rosiglitazone administration and combined pharmaceutical and lifestyle intervention on cardiovascular risk factors Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Rosiglitazone
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2005to Oct 2006
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type II diabetes mellitus
- Poor glycemic control
Who cannot join
- Heart failure
- Renal disease
- Liver disease
- Cardiovascular event
Trial locations and contacts
1 site in 1 country.
Greece1 site
AHEPA University Hospital of Thessaloniki
Thessaloniki, Thessaloniki, 54454
About this study
The aim of the present study is to investigate the influence of systemic exercise, rosiglitazone administration and combined pharmaceutical and lifestyle intervention on cardiovascular risk factors
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Rosiglitazone
- Keywords
- rosiglitazone,exercise,cardiovascular risk factors
- 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.
RosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk factors alterations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startJan 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Athens
- Investigators
- Christos Liapis, PhD,MD, Study chair, University of Athens,Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306176
- Sponsor's protocol ID
- 1975
- Status last verified
- Apr 2007
- First submitted
- 22 Mar 2006
- Last updated
- 4 Apr 2007
- Results posted
- No
Publications
Kadoglou NPE, Korakas E, Lampropoulos S, Maratou E, Kassimis G, Patsourakos N, Plotas P, Moutsatsou P, Lambadiari V. Plasma nesfatin-1 and DDP-4 levels in patients with coronary artery disease: Kozani study. Cardiovasc Diabetol. 2021 Aug 13;20(1):166. doi: 10.1186/s12933-021-01355-x.
PubMed 34389003Kadoglou NP, Vrabas IS, Kapelouzou A, Angelopoulou N. The association of physical activity with novel adipokines in patients with type 2 diabetes. Eur J Intern Med. 2012 Mar;23(2):137-42. doi: 10.1016/j.ejim.2011.10.020. Epub 2011 Nov 29.
PubMed 22284243Kadoglou NP, Vrabas IS, Sailer N, Kapelouzou A, Fotiadis G, Noussios G, Karayannacos PE, Angelopoulou N. Exercise ameliorates serum MMP-9 and TIMP-2 levels in patients with type 2 diabetes. Diabetes Metab. 2010 Apr;36(2):144-51. doi: 10.1016/j.diabet.2009.11.004. Epub 2010 Feb 9.
PubMed 20149706Kadoglou NP, Iliadis F, Angelopoulou N, Sailer N, Fotiadis G, Voliotis K, Vitta I, Liapis CD, Alevizos M. Cardiorespiratory capacity is associated with favourable cardiovascular risk profile in patients with Type 2 diabetes. J Diabetes Complications. 2009 May-Jun;23(3):160-6. doi: 10.1016/j.jdiacomp.2007.12.008. Epub 2008 Apr 16.
PubMed 18413173Kadoglou NP, Iliadis F, Liapis CD, Perrea D, Angelopoulou N, Alevizos M. Beneficial effects of combined treatment with rosiglitazone and exercise on cardiovascular risk factors in patients with type 2 diabetes. Diabetes Care. 2007 Sep;30(9):2242-4. doi: 10.2337/dc07-0341. Epub 2007 Jun 22. No abstract available.
PubMed 17586747
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosiglitazone and Exercise in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00306176
- Acronym / sponsor ID
- 1975
- Conditions
- Type II Diabetes Mellitus
- Keywords
- rosiglitazone,exercise,cardiovascular risk factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- University of Athens
- Study start
- Jan 2005
- Study completion
- Oct 2006
- First posted
- 23 Mar 2006 (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.
The aim of the present study is to investigate the influence of systemic exercise, rosiglitazone administration and combined pharmaceutical and lifestyle intervention on cardiovascular risk factors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type II diabetes mellitus
- Poor glycemic control
Key exclusion criteria (4 listed)
- Heart failure
- Renal disease
- Liver disease
- Cardiovascular event
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 |
|---|---|---|
| Rosiglitazone | Drug | – |
Primary outcome
Cardiovascular risk factors alterations
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 4 Apr 2007.
- Derived from this study: PubMed 34389003Kadoglou NPE, Korakas E, Lampropoulos S, Maratou E, Kassimis G, Patsourakos N, Plotas P, Moutsatsou P, Lambadiari V. Plasma nesfatin-1 and DDP-4 levels in patients with coronary artery disease: Kozani study. Cardiovasc Diabetol. 2021 Aug 13;20(1):166. doi: 10.1186/s12933-021-01355-x.
- Derived from this study: PubMed 22284243Kadoglou NP, Vrabas IS, Kapelouzou A, Angelopoulou N. The association of physical activity with novel adipokines in patients with type 2 diabetes. Eur J Intern Med. 2012 Mar;23(2):137-42. doi: 10.1016/j.ejim.2011.10.020. Epub 2011 Nov 29.
- Derived from this study: PubMed 20149706Kadoglou NP, Vrabas IS, Sailer N, Kapelouzou A, Fotiadis G, Noussios G, Karayannacos PE, Angelopoulou N. Exercise ameliorates serum MMP-9 and TIMP-2 levels in patients with type 2 diabetes. Diabetes Metab. 2010 Apr;36(2):144-51. doi: 10.1016/j.diabet.2009.11.004. Epub 2010 Feb 9.
- Derived from this study: PubMed 18413173Kadoglou NP, Iliadis F, Angelopoulou N, Sailer N, Fotiadis G, Voliotis K, Vitta I, Liapis CD, Alevizos M. Cardiorespiratory capacity is associated with favourable cardiovascular risk profile in patients with Type 2 diabetes. J Diabetes Complications. 2009 May-Jun;23(3):160-6. doi: 10.1016/j.jdiacomp.2007.12.008. Epub 2008 Apr 16.
- Derived from this study: PubMed 17586747Kadoglou NP, Iliadis F, Liapis CD, Perrea D, Angelopoulou N, Alevizos M. Beneficial effects of combined treatment with rosiglitazone and exercise on cardiovascular risk factors in patients with type 2 diabetes. Diabetes Care. 2007 Sep;30(9):2242-4. doi: 10.2337/dc07-0341. Epub 2007 Jun 22. No abstract available.
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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.
Christos Liapis, PhD,MD study chair
University of Athens,Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosiglitazone in people with Type II Diabetes Mellitus, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 2 inclusion and 4 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 4 Apr 2007. 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 Greece. 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.
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.
What does the primary outcome measure?
Cardiovascular risk factors alterations. 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 NCT00306176, which also lists 5 linked publications.
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 4 Apr 2007.