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Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study

NCT ID: NCT01963130

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.

Detailed Description

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Group 1 used metformin (1000 mg bid) and gliclazide (60 mg qd); Group 2 used the same amounts of metformin and gliclazide, with the addition of vildagliptin (50 mg bid). The patients were prospectively assigned to each of these two groups for the purpose of this study. Using Doppler ultrasound, all cases were measured for portal vein flow velocity, portal vein flow and portal vein diameter. Degree of hepatosteatosis was also recorded.

Conditions

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Drug Mechanism Drug Usage

Keywords

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Vildagliptin Portal Vein Pressure Hepatosteatosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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drug (metformin and gliclazide)

The first group (Group 1) consisted of patients that used metformin (1000 mg bid) and gliclazide (60 mg qd).

No interventions assigned to this group

drug (metformin, gliclazide and vildagliptin)

The second group (Group 2) consisted of patients that used vildagliptin (50 mg bid) in addition to the same amount of metformin and gliclazide since their HbA1c were detected 7 % or over.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

-type 2 DM cases and at least 3 months used the same drugs (metformin and gliclazide or metformin and gliclazide and vildagliptin)

Exclusion Criteria

* used alcohol and cigarettes
* chronic liver disease,
* chronic renal failure,
* active infection
* patients using certain drugs which may affect portal pressure such as propronalol,
* calcium channel blockers,
* angiotensin-converting enzyme inhibitors,
* angiotensin receptor blockers and isosorbit monohydrate
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Cumali Karatoprak

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cumali Karatoprak, MD

Role: STUDY_DIRECTOR

Bezmialem VU

Locations

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Bezmialem VU

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ISRCTN73824458

Identifier Type: -

Identifier Source: org_study_id