NCT00696982

Brief Summary

Recently a new category of antihyperglycemic therapy aiming to modulate the incretin system has emerged. These drugs induce insulin secretion without inducing hypoglycemia. The effect of the incretin modulators drugs on hypertension, arterial stiffness, inflammation and oxidative stress parameters have not been fully investigated yet.GLP-1 analogue has been suggested to have an effect on endothelium and the development of hypertension. Nystrom et al have demonstrated that GLP-1 improves endothelial dysfunction in a small group of type 2 diabetes subjects, with coronary heart disease. We hypothesize that DPP-4 inhibitor will have an effect on hypertension and arterial stiffness by effect on the NO pathway.The aim of this study is to investigate the effect of two insulin inducers drugs, sulfonyl urea and DPP-4 inhibitor on 24 hours blood pressure monitoring, arterial stiffness, oxidative stress and inflammation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 13, 2008

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

June 11, 2008

Last Update Submit

June 12, 2008

Conditions

Diabetes MellitusArterial Stiffness

Keywords

Arterial stiffnessAugmentation indexdiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • arterial stiffness, defined as change in augmentation index measured by means of a non-invasive technique using the commercially available SphygmoCor System, and the results of the 24 hour blood pressure monitoring

    6 months

Secondary Outcomes (1)

  • The secondary end results would be oxidative stress parameters, as evaluated by oxidized LDL and Isoprostanes, and markers of inflammatory status, including measurements of pro-inflammatory interleukins and performance of highly sensitive CRP test.

    6 months

Study Arms (2)

A

EXPERIMENTAL

diabetic patients who are treated with metformin wiyh HBA1C\>7% will get sitagliptin

Drug: sitagliptin

B

EXPERIMENTAL

diabetic patients who are treated with metformin with HBA1C\>7% will get glibenclamide

Drug: glibenclamide

Interventions

sitagliptinDRUG

sitagliptin 100 mg once daily for 3 months

A
glibenclamideDRUG

glibenclamide 5 mg once a day titrated as neede up to 20 mg a day

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetic patients
  • aged 18 years or older
  • treated with metformin
  • Only patients with HbA1C levels within the range 7% - 11% will be enrolled in the study

You may not qualify if:

  • CCT\<30
  • A history of treatment with incretins or sulfonylurea during the last 3 months
  • Treatment with nitrates
  • Uncontrolled heart failure
  • Uncontrolled hypertension and/or any change in the hypertensive medications within one month prior starting the study
  • No proven regular treatment with aspirin or statins within one month prior starting the study
  • Any malignancy with life expectancy of less then 1 year
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel

Zrifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitagliptin PhosphateGlyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesSulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Shlomit Koren, MD

    Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shlomit Koren, MD

CONTACT

972-546-888-385shlomitks@gmail.com

Shai Efrati, MD

CONTACT

972-577-346-364efratishai@013.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 13, 2008

Record last verified: 2008-06

Locations

IL(1)