Drug MechanismNCT01963130
Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study
An observational study of Drug Mechanism and Drug Usage, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug Mechanism, Drug Usage
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 2 Diabetes Mellitus (DM)
Who may be able to join
- -type 2 DM cases and at least 3 months used the same drugs (metformin and gliclazide or metformin and gliclazide and vildagliptin)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Drug Mechanism, Drug Usage
- Keywords
- Vildagliptin, Portal Vein Pressure, Hepatosteatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: followed for at least 3 months (mean 7.8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug MechanismStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cumali Karatoprak, Bezmialem Vakif University
- Investigators
- Cumali Karatoprak, MD, Study director, Bezmialem VU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963130
- Sponsor's protocol ID
- ISRCTN73824458
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT01963130
- Acronym / sponsor ID
- ISRCTN73824458
- Conditions
- Drug Mechanism, Drug Usage
- Keywords
- Vildagliptin, Portal Vein Pressure, Hepatosteatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 Diabetes Mellitus (DM)
Key inclusion criteria (1 listed)
- -type 2 DM cases and at least 3 months used the same drugs (metformin and gliclazide or metformin and gliclazide and vildagliptin)
Key exclusion criteria (8 listed)
- used alcohol and cigarettes
- chronic liver disease,
- chronic renal failure,
- active infection
- patients using certain drugs which may affect portal pressure such as propronalol,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cumali Karatoprak, MD study director
Bezmialem VU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Mechanism and Drug Usage, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.