HealthyPhase 3NCT02406950
Sitagliptin and Endothelial Dysfunction
A Phase 3 study testing Sitagliptin in people with Healthy, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal ischemia-reperfusion (IR) injuries. There is little study whether sitagliptin protects against endothelial dysfunction induced by IR injury in humans. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Aug 2015
- Phase
- Phase 3
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer age 20 to 40 years
- non-smoker
Who cannot join
- High blood pressure (>140/90 mmHg) or any antihypertensive medications
- diabetes
- any cardiovascular disease
- kidney disease
- thyroid disease
- cerebrovascular disease
Show all 9Show fewer
- liver disease (bilirubin level >2 mg/dl)
- pregnancy
- body mass index >25 kg/m2
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital
Seoul, Seoul, 130-872
Weon Kim, MD, PhD, 2-958-8170 ext. 82, mylovekw@hanmail.net
Jong Shin Woo, MD, 2-958-8176 ext. 82, snowball77@hanmail.net
About this study
Official title: Preventive Effects of Sitagliptin on Endothelial Dysfunction Induced by Forearm Ischemia-Reperfusion Injury Model
Over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal ischemia-reperfusion (IR) injuries. There is little study whether sitagliptin protects against endothelial dysfunction induced by IR injury in humans.
Read the detailed description
Glucagon-like peptide-1 (GLP-1) is a novel insulinotropic peptide which is rapidly degraded by the enzyme dipeptidyl peptidase-4 (DPP-4). In addition to its attractive merit in type 2 diabetes, interest in the cardioprotective effects of GLP-1 has been increased with various reports and evidence. Previously, the investigators could show exenatide, GLP-1 receptor agonist protects ischemic/reperfusion injury-induced endothelial dysfunction through opening of KATP (ATP-sensitive potassium) channels in human ischemic/reperfusion injury model. But, recent clinical studies showed 2 different DPP-4 inhibitors, alogliptin and saxagliptin, did not decrease major adverse cardiovascular events even though improving glycemic control. The investigators will investigate the role of sitagliptin in human ischemic/reperfusion (IR) injury model of forearm conductance vessels as previous described method.
- Conditions
- Healthy
- Being tested
- Sitagliptin
- Keywords
- Sitagliptin, Endothelium, Ischemia-Reperfusion Injury, human
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
The brachial FMD before and after IR injury will be assessed. After randomization, study medication will be treated. In 2 hours later, the brachial FMD before and after IR injury will be assessed again. All volunteers had a wash-out period of 7 days. Seven days later, the subjects returned to crossover study medication (ie, sitagliptin or placebo), and the protocol described above was repeated.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | All participant will exam brachial artery endothelium-dependent flow-mediated dilatation (FMD). After then, pneumatic cuff wiil be inflated to 200 mmHg for 15 minutes to induce brachial artery ischemia. At the end of ischemia, 15 minutes of reperfusion was performed to induce reperfusion injury. After ischemia-reperfusion (IR) injury, brachial artery FMD will be measured again. After randomization, sitagliptin group will be treated by single dose of sitagliptin (Januvia) 50mg. In 2 hours later, brachial artery FMD measurement, IR injury and brachial artery FMD measurement will be measured again. Receives: Drug: Sitagliptin |
| Placebo | Placebo comparator | After brachial artery FMD measurement, IR injury for each 15 minutes will be performed, and brachial artery FMD will be measured again. After randomization, placebo group will be treated by nothing. In 2 hours later, brachial artery FMD measurement, IR injury and brachial artery FMD measurement will be measured again. |
| Sitagliptin and glibenclimide | Other | If sitagliptin treatment show preventive effects of IR injury, the investigator will perform additional experiment to explore the mechanism (Protocol 2 study). Additional 15 healthy volunteers will be treated 5 mg of glibenclamide (Euglucon) 1 hour before administration of 50 m g of sitagliptin. In 2 hours after sitagliptin administration, FMD measurement before and after IR injury will be performed as described above. Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of FMD [brachial artery endothelium-dependent flow-mediated dilatation] after IR injury (brachial FMD before and after IR injury will be assessed)
Measured: 2 hours after study drug treatment
Secondary outcomes (1)
The difference of FMD after IR injury in co-treatment of glibenclimide and sitagliptin ((brachial FMD before and after IR injury will be assessed)
Measured: 3.5 hours after study drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weon Kim, Kyunghee University Medical Center
- Investigators
- Weon Kim, MD, PhD, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406950
- Sponsor's protocol ID
- Signal
- Status last verified
- Mar 2015
- First submitted
- 14 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effects of Sitagliptin on Endothelial Dysfunction Induced by Forearm Ischemia-Reperfusion Injury Model
- ClinicalTrials.gov ID
- NCT02406950
- Acronym / sponsor ID
- Signal
- Conditions
- Healthy
- Keywords
- Sitagliptin, Endothelium, Ischemia-Reperfusion Injury, human
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 2 Apr 2015 (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.
Over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal ischemia-reperfusion (IR) injuries. There is little study whether sitagliptin protects against endothelial dysfunction induced by IR injury in humans.
Detailed description
Glucagon-like peptide-1 (GLP-1) is a novel insulinotropic peptide which is rapidly degraded by the enzyme dipeptidyl peptidase-4 (DPP-4). In addition to its attractive merit in type 2 diabetes, interest in the cardioprotective effects of GLP-1 has been increased with various reports and evidence. Previously, the investigators could show exenatide, GLP-1 receptor agonist protects ischemic/reperfusion injury-induced endothelial dysfunction through opening of KATP (ATP-sensitive potassium) channels in human ischemic/reperfusion injury model. But, recent clinical studies showed 2 different DPP-4 inhibitors, alogliptin and saxagliptin, did not decrease major adverse cardiovascular events even though improving glycemic control. The investigators will investigate the role of sitagliptin in human ischemic/reperfusion (IR) injury model of forearm conductance vessels as previous described method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: SitagliptinAll participant will exam brachial artery endothelium-dependent flow-mediated dilatation (FMD). After then, pneumatic cuff wiil be inflated to 200 mmHg for 15 minutes to induce brachial artery ischemia. At the end of ischemia, 15 minutes of reperfusion was performed to induce reperfusion injury. After ischemia-reperfusion (IR) injury, brachial artery FMD will be measured again. After randomization, sitagliptin group will be treated by single dose of sitagliptin (Januvia) 50mg. In 2 hours later, brachial artery FMD measurement, IR injury and brachial artery FMD measurement will be measured again. |
| Placebo | Placebo comparator | –After brachial artery FMD measurement, IR injury for each 15 minutes will be performed, and brachial artery FMD will be measured again. After randomization, placebo group will be treated by nothing. In 2 hours later, brachial artery FMD measurement, IR injury and brachial artery FMD measurement will be measured again. |
| Sitagliptin and glibenclimide | Other | Drug: SitagliptinIf sitagliptin treatment show preventive effects of IR injury, the investigator will perform additional experiment to explore the mechanism (Protocol 2 study). Additional 15 healthy volunteers will be treated 5 mg of glibenclamide (Euglucon) 1 hour before administration of 50 m g of sitagliptin. In 2 hours after sitagliptin administration, FMD measurement before and after IR injury will be performed as described above. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteer age 20 to 40 years
- non-smoker
Key exclusion criteria (9 listed)
- High blood pressure (>140/90 mmHg) or any antihypertensive medications
- diabetes
- any cardiovascular disease
- kidney disease
- thyroid disease
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 |
|---|---|---|
| SitagliptinAlso: JanuviaThe brachial FMD before and after IR injury will be assessed. After randomization, study medication will be treated. In 2 hours later, the brachial FMD before and after IR injury will be assessed again. All volunteers had a wash-out period of 7 days. Seven days later, the subjects returned to crossover study medication (ie, sitagliptin or placebo), and the protocol described above was repeated. | Drug | Sitagliptin, Sitagliptin and glibenclimide |
Primary outcome
The difference of FMD [brachial artery endothelium-dependent flow-mediated dilatation] after IR injury (brachial FMD before and after IR injury will be assessed)
Time frame: 2 hours after study drug treatment
1 secondary outcome
The difference of FMD after IR injury in co-treatment of glibenclimide and sitagliptin ((brachial FMD before and after IR injury will be assessed)
Time frame: 3.5 hours after study drug treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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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.
Weon Kim, MD, PhD principal investigator
Kyunghee University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitagliptin in people with Healthy, run by Kyunghee University Medical Center 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 2 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 2 Apr 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Weon Kim, MD, PhD (82-2-958-8170, mylovekw@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of FMD [brachial artery endothelium-dependent flow-mediated dilatation] after IR injury (brachial FMD before and after IR injury will be assessed) (time frame: 2 hours after study drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2015.