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Sitagliptin and Endothelial Dysfunction

Primary Purpose

Healthy

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sitagliptin
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Sitagliptin, Endothelium, Ischemia-Reperfusion Injury, human

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Kyung Hee University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Sitagliptin

Placebo

Sitagliptin and glibenclimide

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The difference of FMD after IR injury in co-treatment of glibenclimide and sitagliptin ((brachial FMD before and after IR injury will be assessed)

Full Information

First Posted
March 14, 2015
Last Updated
April 1, 2015
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02406950
Brief Title
Sitagliptin and Endothelial Dysfunction
Official Title
Preventive Effects of Sitagliptin on Endothelial Dysfunction Induced by Forearm Ischemia-Reperfusion Injury Model
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Sitagliptin, Endothelium, Ischemia-Reperfusion Injury, human

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Sitagliptin and glibenclimide
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Adverse events such as hypoglycemia
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteer age 20 to 40 years non-smoker Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weon Kim, MD, PhD
Phone
82-2-958-8170
Email
mylovekw@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Shin Woo, MD, PhD
Phone
82-2-958-8176
Email
snowball77@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weon Kim, MD, PhD
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weon Kim, MD, PhD
Phone
2-958-8170
Ext
82
Email
mylovekw@hanmail.net
First Name & Middle Initial & Last Name & Degree
Jong Shin Woo, MD
Phone
2-958-8176
Ext
82
Email
snowball77@hanmail.net
First Name & Middle Initial & Last Name & Degree
Jong Shin Woo, MD

12. IPD Sharing Statement

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Sitagliptin and Endothelial Dysfunction

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