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

Study Overview
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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.

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

Conditions
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Drug Mechanism, Drug Usage

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| drug (metformin and gliclazide)<br>The first group (Group 1) consisted of patients that used metformin (1000 mg bid) and gliclazide (60 mg qd). | |
| drug (metformin, gliclazide and vildagliptin)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on portal hemodynamics. | 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. | at least 3 month (mean 7.8 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on hepatosteatosis. | 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 | followed for at least 3 months (mean 7.8 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vildagliptin, Portal Vein Pressure, Hepatosteatosis