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

Drug Usage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963130
• Other study ID #: ISRCTN73824458
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: October 11, 2013
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Drug Mechanism
• Drug Usage

Locations

Country	Name	City	State
Turkey	Bezmialem VU	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes