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

Completed

• Conditions: Drug Mechanism; Drug Usage

• Registration Number: NCT01963130
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Last Update Submitted: 2013-10-11
• Study First Posted: 2013-10-16
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on portal hemodynamics.	at least 3 month (mean 7.8 months)	This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal vein pressure in patients with type 2 diabetes mellitus. Portal vein flow velocity, portal vein flow, and portal vein diameter of all cases were measured by Doppler ultrasound in both groups.

Secondary Outcome Measures

Name	Time	Method
This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on hepatosteatosis.	followed for at least 3 months (mean 7.8 months)	Patients were examined in the left decubitus position with a Logiq 9 Review (GE, Milwaukee, WI, USA) ultrasound device and a 3.5-mHz convex transducer probe was used. Gray scale and color Doppler features were used. All segments of the liver were examined and the presence and degree of hepatosteatosis was recorded

Trial Locations

Locations (1)

Bezmialem VU; 🇹🇷 Istanbul, Turkey