Diabetes Mellitus, Type 2Phase 4NCT00300911
Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction
A Phase 4 study testing Rosiglitazone(drug), cardiac adverse effects in people with Diabetes Mellitus, Type 2, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function compared with metformin Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rosiglitazone(drug), cardiac adverse effects
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2005to 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus treated with oral hypoglycemic agents or diet only
- Without any symptom or finding of heart failure
- Normal liver enzymes and renal functions
Who cannot join
- Any known coronary artery disease, congestive hearth failure, renal disease or liver disease
- Any treatment for heart failure or diuretics for any reasons.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Ankara Hospital
Ankara, 06490
About this study
Official title: A Study of PPAR-Gamma Agonist-Rosiglitazone for Determining Cardiac Adverse Effects in Type 2 Diabetic Patients
The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function compared with metformin
Read the detailed description
Large scale clinical trials have reported fluid retention and increase in plasma volume (6% to 7%) with glitazone therapy, with an increased incidence of peripheral edema occuring in 2% to 5% patients. Some evidence suggests that this effect may be related to increased endothelial cell permeability induced by glitazones therapy. Others report that glitazones may interfere with renal hemodynamics. In controlled clinical trials, the frequency of new onset congestive heart failure was very low in glitazones treated patients. The incidence of congestive heart failure is higher in patients receiving combination therapy with insulin and glitazones. Only few studies compared rosiglitazone and metformin on cardiac safety. Recently a study reported a reversible increase in endothelial cell permeability to albumin in cultured pulmonary arterial cells treated with rosiglitazone. To our knowledge, there is not any clinical study published for showing the reversibility of the cardiac adverse effects if the rosiglitazone treatment is continued.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rosiglitazone(drug), cardiac adverse effects
- Keywords
- Natriuretic Peptide, Brain, Heart Failure, Congestive
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosiglitazone(drug), cardiac adverse effectsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Brain Natriuretic Peptide levels, echocardiographic measurements were made before the treatment and repeated after three months and six months of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Investigators
- Yasemin T Kemal, MD, Study director, Medical Doctor, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300911
- Sponsor's protocol ID
- KA04/164
- Status last verified
- Nov 2005
- First submitted
- 9 Mar 2006
- Last updated
- 10 Mar 2006
- Results posted
- No
Publications
Niemeyer NV, Janney LM. Thiazolidinedione-induced edema. Pharmacotherapy. 2002 Jul;22(7):924-9. doi: 10.1592/phco.22.11.924.33626.
PubMed 12126225Wooltorton E. Rosiglitazone (Avandia) and pioglitazone (Actos) and heart failure. CMAJ. 2002 Jan 22;166(2):219. No abstract available.
PubMed 11826947Idris I, Gray S, Donnelly R. Rosiglitazone and pulmonary oedema: an acute dose-dependent effect on human endothelial cell permeability. Diabetologia. 2003 Feb;46(2):288-90. doi: 10.1007/s00125-002-1008-1. Epub 2003 Feb 12.
PubMed 12627329Maeda K, Tsutamoto T, Wada A, Hisanaga T, Kinoshita M. Plasma brain natriuretic peptide as a biochemical marker of high left ventricular end-diastolic pressure in patients with symptomatic left ventricular dysfunction. Am Heart J. 1998 May;135(5 Pt 1):825-32. doi: 10.1016/s0002-8703(98)70041-9.
PubMed 9588412Lubien E, DeMaria A, Krishnaswamy P, Clopton P, Koon J, Kazanegra R, Gardetto N, Wanner E, Maisel AS. Utility of B-natriuretic peptide in detecting diastolic dysfunction: comparison with Doppler velocity recordings. Circulation. 2002 Feb 5;105(5):595-601. doi: 10.1161/hc0502.103010.
PubMed 11827925Ogawa S, Takeuchi K, Ito S. Plasma BNP levels in the treatment of type 2 diabetes with pioglitazone. J Clin Endocrinol Metab. 2003 Aug;88(8):3993-6. doi: 10.1210/jc.2002-021765.
PubMed 12915698
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of PPAR-Gamma Agonist-Rosiglitazone for Determining Cardiac Adverse Effects in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00300911
- Acronym / sponsor ID
- KA04/164
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Natriuretic Peptide, Brain, Heart Failure, Congestive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Dec 2005
- First posted
- 10 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 present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function compared with metformin
Detailed description
Large scale clinical trials have reported fluid retention and increase in plasma volume (6% to 7%) with glitazone therapy, with an increased incidence of peripheral edema occuring in 2% to 5% patients. Some evidence suggests that this effect may be related to increased endothelial cell permeability induced by glitazones therapy. Others report that glitazones may interfere with renal hemodynamics. In controlled clinical trials, the frequency of new onset congestive heart failure was very low in glitazones treated patients. The incidence of congestive heart failure is higher in patients receiving combination therapy with insulin and glitazones. Only few studies compared rosiglitazone and metformin on cardiac safety. Recently a study reported a reversible increase in endothelial cell permeability to albumin in cultured pulmonary arterial cells treated with rosiglitazone. To our knowledge, there is not any clinical study published for showing the reversibility of the cardiac adverse effects if the rosiglitazone treatment is continued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus treated with oral hypoglycemic agents or diet only
- Without any symptom or finding of heart failure
- Normal liver enzymes and renal functions
Key exclusion criteria (2 listed)
- Any known coronary artery disease, congestive hearth failure, renal disease or liver disease
- Any treatment for heart failure or diuretics for any reasons.
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), cardiac adverse effects | Drug | – |
Primary outcome
Plasma Brain Natriuretic Peptide levels, echocardiographic measurements were made before the treatment and repeated after three months and six months of the treatment
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 10 Mar 2006.
- Background: PubMed 12126225Niemeyer NV, Janney LM. Thiazolidinedione-induced edema. Pharmacotherapy. 2002 Jul;22(7):924-9. doi: 10.1592/phco.22.11.924.33626.
- Background: PubMed 11826947Wooltorton E. Rosiglitazone (Avandia) and pioglitazone (Actos) and heart failure. CMAJ. 2002 Jan 22;166(2):219. No abstract available.
- Background: PubMed 12627329Idris I, Gray S, Donnelly R. Rosiglitazone and pulmonary oedema: an acute dose-dependent effect on human endothelial cell permeability. Diabetologia. 2003 Feb;46(2):288-90. doi: 10.1007/s00125-002-1008-1. Epub 2003 Feb 12.
- Background: PubMed 9588412Maeda K, Tsutamoto T, Wada A, Hisanaga T, Kinoshita M. Plasma brain natriuretic peptide as a biochemical marker of high left ventricular end-diastolic pressure in patients with symptomatic left ventricular dysfunction. Am Heart J. 1998 May;135(5 Pt 1):825-32. doi: 10.1016/s0002-8703(98)70041-9.
- Background: PubMed 11827925Lubien E, DeMaria A, Krishnaswamy P, Clopton P, Koon J, Kazanegra R, Gardetto N, Wanner E, Maisel AS. Utility of B-natriuretic peptide in detecting diastolic dysfunction: comparison with Doppler velocity recordings. Circulation. 2002 Feb 5;105(5):595-601. doi: 10.1161/hc0502.103010.
- Background: PubMed 12915698Ogawa S, Takeuchi K, Ito S. Plasma BNP levels in the treatment of type 2 diabetes with pioglitazone. J Clin Endocrinol Metab. 2003 Aug;88(8):3993-6. doi: 10.1210/jc.2002-021765.
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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.
Yasemin T Kemal, MD study director
Medical Doctor, Internal Medicine
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(drug), cardiac adverse effects in people with Diabetes Mellitus, Type 2, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 10 Mar 2006. 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 Turkey (Türkiye). 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?
Plasma Brain Natriuretic Peptide levels, echocardiographic measurements were made before the treatment and repeated after three months and six months of the treatment. 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 NCT00300911, which also lists 6 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 10 Mar 2006.