Diabetes Mellitus, Type 2Phase 4NCT00290394
Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients
A Phase 4 study testing rosiglitazone(drug), blood pressure lowering effect in people with Diabetes Mellitus, Type 2, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to determine the effects of rosiglitazone in normotensive type 2 diabetic patients with regard to its blood-pressure-reducing effects. Read more about this study
- Who is it for?
- Ages 49 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- rosiglitazone(drug), blood pressure lowering effect
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2004to Aug 2004
- 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 49 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blood pressure of patients were in normotensive limits according to the JNC VII
- Diabetes mellitus treated with oral antidiabetics or diet
Who cannot join
- Any known hypertension, coronary artery disease, congestive hearth failure, renal disease or liver disease
- Anti-hypertensive treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Ankara Hospital
Ankara, 06490
About this study
Official title: Study of PPAR Gamma Agonist-Rosiglitazone in Normotensive Type 2 Diabetics With Ambulatory Blood Pressure Monitoring
The purpose of this study was to determine the effects of rosiglitazone in normotensive type 2 diabetic patients with regard to its blood-pressure-reducing effects.
Read the detailed description
The first study to evaluate the effects of troglitazone on blood pressure in humans was published recently, which demonstrated a 5/4 mm Hg reduction in ambulatory blood pressure in 18 nondiabetic obese subjects after 12 weeks' treatment. Another study in 18 hypertensive subjects with diabetes mellitus showed an 18/12 mm Hg decline in office blood pressure after 8 weeks of treatment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- rosiglitazone(drug), blood pressure lowering effect
- Keywords
- Blood Pressure,, rosiglitazone,Diabetes Mellitus, Type 2,
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazone(drug), blood pressure lowering effectDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure monitors used to determine the subjects blood pressure before and after the treatment. At the end of three months period wit rosiglitazone treatment diastolic blood pressure decreased.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startMar 2004
- Study completionAug 2004
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Investigators
- Neslihan B Tutuncu, MD, Study director, Medical Doctor, Endocrynology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290394
- Sponsor's protocol ID
- KA03/181
- Status last verified
- Mar 2004
- First submitted
- 9 Feb 2006
- Last updated
- 13 Feb 2006
- Results posted
- No
Publications
Takano H, Komuro I. Roles of peroxisome proliferator-activated receptor gamma in cardiovascular disease. J Diabetes Complications. 2002 Jan-Feb;16(1):108-14. doi: 10.1016/s1056-8727(01)00203-3.
PubMed 11872377Walker AB, Naderali EK, Chattington PD, Buckingham RE, Williams G. Differential vasoactive effects of the insulin sensitizers rosiglitazone (BRL 49653) and troglitazone on human small arteries in vitro. Diabetes. 1998 May;47(5):810-4. doi: 10.2337/diabetes.47.5.810.
PubMed 9588454Fujishima S, Ohya Y, Nakamura Y, Onaka U, Abe I, Fujishima M. Troglitazone, an insulin sensitizer, increases forearm blood flow in humans. Am J Hypertens. 1998 Sep;11(9):1134-7. doi: 10.1016/s0895-7061(98)00130-7.
PubMed 9752901Chen S, Noguchi Y, Izumida T, Tatebe J, Katayama S. A comparison of the hypotensive and hypoglycaemic actions of an angiotensin converting enzyme inhibitor, an AT1a antagonist and troglitazone. J Hypertens. 1996 Nov;14(11):1325-30. doi: 10.1097/00004872-199611000-00011.
PubMed 8934361Saku K, Zhang B, Ohta T, Arakawa K. Troglitazone lowers blood pressure and enhances insulin sensitivity in Watanabe heritable hyperlipidemic rabbits. Am J Hypertens. 1997 Sep;10(9 Pt 1):1027-33. doi: 10.1016/s0895-7061(97)00160-x.
PubMed 9324109Nolan JJ, Ludvik B, Beerdsen P, Joyce M, Olefsky J. Improvement in glucose tolerance and insulin resistance in obese subjects treated with troglitazone. N Engl J Med. 1994 Nov 3;331(18):1188-93. doi: 10.1056/NEJM199411033311803.
PubMed 7935656
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PPAR Gamma Agonist-Rosiglitazone in Normotensive Type 2 Diabetics With Ambulatory Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT00290394
- Acronym / sponsor ID
- KA03/181
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Blood Pressure,, rosiglitazone,Diabetes Mellitus, Type 2,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Aug 2004
- First posted
- 13 Feb 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 purpose of this study was to determine the effects of rosiglitazone in normotensive type 2 diabetic patients with regard to its blood-pressure-reducing effects.
Detailed description
The first study to evaluate the effects of troglitazone on blood pressure in humans was published recently, which demonstrated a 5/4 mm Hg reduction in ambulatory blood pressure in 18 nondiabetic obese subjects after 12 weeks' treatment. Another study in 18 hypertensive subjects with diabetes mellitus showed an 18/12 mm Hg decline in office blood pressure after 8 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 49 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Blood pressure of patients were in normotensive limits according to the JNC VII
- Diabetes mellitus treated with oral antidiabetics or diet
Key exclusion criteria (2 listed)
- Any known hypertension, coronary artery disease, congestive hearth failure, renal disease or liver disease
- Anti-hypertensive treatment
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), blood pressure lowering effect | Drug | – |
Primary outcome
Ambulatory blood pressure monitors used to determine the subjects blood pressure before and after the treatment. At the end of three months period wit rosiglitazone treatment diastolic blood pressure decreased.
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 13 Feb 2006.
- Background: PubMed 11872377Takano H, Komuro I. Roles of peroxisome proliferator-activated receptor gamma in cardiovascular disease. J Diabetes Complications. 2002 Jan-Feb;16(1):108-14. doi: 10.1016/s1056-8727(01)00203-3.
- Background: PubMed 9588454Walker AB, Naderali EK, Chattington PD, Buckingham RE, Williams G. Differential vasoactive effects of the insulin sensitizers rosiglitazone (BRL 49653) and troglitazone on human small arteries in vitro. Diabetes. 1998 May;47(5):810-4. doi: 10.2337/diabetes.47.5.810.
- Background: PubMed 9752901Fujishima S, Ohya Y, Nakamura Y, Onaka U, Abe I, Fujishima M. Troglitazone, an insulin sensitizer, increases forearm blood flow in humans. Am J Hypertens. 1998 Sep;11(9):1134-7. doi: 10.1016/s0895-7061(98)00130-7.
- Background: PubMed 8934361Chen S, Noguchi Y, Izumida T, Tatebe J, Katayama S. A comparison of the hypotensive and hypoglycaemic actions of an angiotensin converting enzyme inhibitor, an AT1a antagonist and troglitazone. J Hypertens. 1996 Nov;14(11):1325-30. doi: 10.1097/00004872-199611000-00011.
- Background: PubMed 9324109Saku K, Zhang B, Ohta T, Arakawa K. Troglitazone lowers blood pressure and enhances insulin sensitivity in Watanabe heritable hyperlipidemic rabbits. Am J Hypertens. 1997 Sep;10(9 Pt 1):1027-33. doi: 10.1016/s0895-7061(97)00160-x.
- Background: PubMed 7935656Nolan JJ, Ludvik B, Beerdsen P, Joyce M, Olefsky J. Improvement in glucose tolerance and insulin resistance in obese subjects treated with troglitazone. N Engl J Med. 1994 Nov 3;331(18):1188-93. doi: 10.1056/NEJM199411033311803.
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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.
Neslihan B Tutuncu, MD study director
Medical Doctor, Endocrynology
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), blood pressure lowering effect 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 2 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 13 Feb 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?
Ambulatory blood pressure monitors used to determine the subjects blood pressure before and after the treatment. At the end of three months period wit rosiglitazone treatment diastolic blood pressure decreased.. 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 NCT00290394, 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 13 Feb 2006.