NCT02406950

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_3 healthy

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

March 14, 2015

Last Update Submit

April 1, 2015

Conditions

Healthy

Keywords

SitagliptinEndotheliumIschemia-Reperfusion Injuryhuman

Outcome Measures

Primary Outcomes (1)

  • The difference of FMD [brachial artery endothelium-dependent flow-mediated dilatation] after IR injury (brachial FMD before and after IR injury will be assessed)

    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)

    3.5 hours after study drug treatment

Other Outcomes (1)

  • Adverse events

    3 weeks

Study Arms (3)

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.

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.

Drug: Sitagliptin

Interventions

SitagliptinDRUG

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.

Also known as: Januvia
SitagliptinSitagliptin and glibenclimide

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteer age 20 to 40 years
  • non-smoker

You may not qualify if:

  • High blood pressure (\>140/90 mmHg) or any antihypertensive medications
  • diabetes
  • any cardiovascular disease
  • kidney disease
  • thyroid disease
  • cerebrovascular disease
  • liver disease (bilirubin level \>2 mg/dl)
  • pregnancy
  • body mass index \>25 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital

Seoul, Seoul, 130-872, South Korea

RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Weon Kim, MD, PhD

    Kyunghee University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weon Kim, MD, PhD

CONTACT

82-2-958-8170mylovekw@hanmail.net

Jong Shin Woo, MD, PhD

CONTACT

82-2-958-8176snowball77@hanmail.net

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2015

First Posted

April 2, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations

KR(1)