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

NCT01963130 | Completed

• 1 other identifier: ISRCTN73824458
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Mechanism; Drug Usage

Keywords

Vildagliptin; Portal Vein Pressure; Hepatosteatosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

drug (metformin and gliclazide)

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

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

type 2 Diabetes Mellitus (DM)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem VU

Istanbul, 34093, Turkey (Türkiye)

Location

Study Officials

• Cumali Karatoprak, MD

  Bezmialem VU

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 16, 2013
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

TU (1)