Diabetes Mellitus, Type 2Phase 4NCT00573950
Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness
A Phase 4 study testing cilostazol in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome X, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication. Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and inhibitor of platelet aggregation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metabolic Syndrome X
- What is being tested?
- cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Dec 2008
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Hypertensive patients with the use of ACE inhibitor or ARB
- Hyperlipidemic patients with the use of statin or fenofibrate
- Hepatic dysfunction
- Chronic alcohol or drug abuse
- Renal dysfunction
- Heart failure
Show all 9Show fewer
- Patients who takes hormone replace therapy or steroid containing drugs
- Patients who take drugs like anticoagulant (warfarin), anti-platelet agent (aspirin, ticlopidin), thrombolytic agent (urikinase, alteplase), prostaglandine E1 , drugs inhibit CYP3A4 or CYP2C19, or drugs become substrate of CYP3A4
- Patients who haves disease influencing the results of the study such as neurologic, digestive and neoplastic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea Univerisity Anam Hospital
Seoul, 136-705
Dong Kim, +82-2-920-6566, ctcan@kumc.or.kr
About this study
Official title: Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness in Type 2 Diabetes Patient With Metabolic Syndrome (Randomized, Double-Blind, Placebo-Controled, Cross-Over Study)
Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication. Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and inhibitor of platelet aggregation. Recently there were report of beneficial effect of cilostazol like vasodilation, lipid metabolism, and cytokine production. But there were few clinical studies that support these effects of cilostazol. The purpose of this study is to evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by PWV and plasma adipocytokines.
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Syndrome X
- Being tested
- cilostazol, Placebo
- Keywords
- cilostazol, Type 2 Diabetes mellitus, Metabolic Syndrome, adipocytokines, arterial stiffness, Pulse wave velocity
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cilostazolDrug
Also called pletaal
50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
PlaceboDrug
Placebo tablet comparable to 50mg cilostazol two times a day for 2 weeks and then placebo tablet comparable to 100mg cilostazol two times a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Experimental | cilostazol group Receives: Drug: cilostazol |
| Placebo | Placebo comparator | placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect on pulse wave velocity (PWV)
Measured: 8 weeks
Secondary outcomes (1)
the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startDec 2007
- Study completionDec 2008 (estimated)
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 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sin Gon Kim, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573950
- Sponsor's protocol ID
- cilostaar
- Status last verified
- Dec 2007
- First submitted
- 13 Dec 2007
- Last updated
- 14 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim NH, Kim HY, An H, Seo JA, Kim NH, Choi KM, Baik SH, Choi DS, Kim SG. Effect of cilostazol on arterial stiffness and vascular adhesion molecules in type 2 diabetic patients with metabolic syndrome: a randomised, double-blind, placebo-controlled, crossover trial. Diabetol Metab Syndr. 2013 Jul 26;5(1):41. doi: 10.1186/1758-5996-5-41.
PubMed 23886346
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness in Type 2 Diabetes Patient With Metabolic Syndrome (Randomized, Double-Blind, Placebo-Controled, Cross-Over Study)
- ClinicalTrials.gov ID
- NCT00573950
- Acronym / sponsor ID
- cilostaar
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Syndrome X
- Keywords
- cilostazol, Type 2 Diabetes mellitus, Metabolic Syndrome, adipocytokines, arterial stiffness, Pulse wave velocity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 14 Dec 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.
Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication. Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and inhibitor of platelet aggregation. Recently there were report of beneficial effect of cilostazol like vasodilation, lipid metabolism, and cytokine production. But there were few clinical studies that support these effects of cilostazol. The purpose of this study is to evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by PWV and plasma adipocytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Experimental | Drug: cilostazolcilostazol group |
| Placebo | Placebo comparator | Drug: Placeboplacebo group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Hypertensive patients with the use of ACE inhibitor or ARB
- Hyperlipidemic patients with the use of statin or fenofibrate
- Hepatic dysfunction
- Chronic alcohol or drug abuse
- Renal dysfunction
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 |
|---|---|---|
| cilostazolAlso: pletaal50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks | Drug | Cilostazol |
| PlaceboPlacebo tablet comparable to 50mg cilostazol two times a day for 2 weeks and then placebo tablet comparable to 100mg cilostazol two times a day for 6 weeks | Drug | Placebo |
Primary outcome
The effect on pulse wave velocity (PWV)
Time frame: 8 weeks
1 secondary outcome
the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2007.
- Derived from this study: PubMed 23886346Kim NH, Kim HY, An H, Seo JA, Kim NH, Choi KM, Baik SH, Choi DS, Kim SG. Effect of cilostazol on arterial stiffness and vascular adhesion molecules in type 2 diabetic patients with metabolic syndrome: a randomised, double-blind, placebo-controlled, crossover trial. Diabetol Metab Syndr. 2013 Jul 26;5(1):41. doi: 10.1186/1758-5996-5-41.
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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.
Sin Gon Kim, MD, PhD principal investigator
Korea University Anam Hospital
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 cilostazol in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome X, run by Korea University Anam Hospital at 1 site in South Korea.
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 0 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Dec 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Young Kim, MD, PhD (+82-2-920-5767, lynsette@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect on pulse wave velocity (PWV) (time frame: 8 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 NCT00573950, 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 14 Dec 2007.