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

Bezmialem Vakif University

Status: Completed

Conditions: Drug Mechanism; Drug Usage

Study type: Observational

Funder types: Other

Identifiers

NCT01963130

ISRCTN73824458

Details and patient eligibility

About

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

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

97 participants in 2 patient groups

drug (metformin and gliclazide)

Description:

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

drug (metformin, gliclazide and vildagliptin)

Description:

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.