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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumali Karatoprak, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT01963130
First received: October 10, 2013
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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


Condition
Drug Mechanism
Drug Usage

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study

Resource links provided by NLM:


Further study details as provided by Bezmialem Vakif University:

Primary Outcome Measures:
  • This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on portal hemodynamics. [ Time Frame: at least 3 month (mean 7.8 months) ] [ Designated as safety issue: Yes ]
    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:
  • This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on hepatosteatosis. [ Time Frame: followed for at least 3 months (mean 7.8 months) ] [ Designated as safety issue: Yes ]
    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


Enrollment: 97
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

type 2 Diabetes Mellitus (DM)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963130

Locations
Turkey
Bezmialem VU
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
Study Director: Cumali Karatoprak, MD Bezmialem VU
  More Information

No publications provided

Responsible Party: Cumali Karatoprak, MD, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01963130     History of Changes
Other Study ID Numbers: ISRCTN73824458
Study First Received: October 10, 2013
Last Updated: October 11, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Bezmialem Vakif University:
Vildagliptin
Portal Vein Pressure
Hepatosteatosis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014