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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

October 10, 2013
October 11, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01963130 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study
Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study

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

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

type 2 Diabetes Mellitus (DM)

  • Drug Mechanism
  • Drug Usage
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01963130
ISRCTN73824458
No
Cumali Karatoprak, Bezmialem Vakif University
Bezmialem Vakif University
Not Provided
Study Director: Cumali Karatoprak, MD Bezmialem VU
Bezmialem Vakif University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP