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The Effect of Sitagliptin on Hypertension, Arterial Stiffness, Oxidative Stress and Inflammation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00696982
First received: June 11, 2008
Last updated: June 12, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Arterial Stiffness
 Drug: sitagliptin
Drug: glibenclamide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Effect of Sitagliptin on Hypertension, Arterial Stiffness, Oxidative Stress and Inflammation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
diabetic patients who are treated with metformin wiyh HBA1C>7% will get sitagliptin
 Drug: sitagliptin
sitagliptin 100 mg once daily for 3 months
Other Name: sitagliptin
Experimental: B
diabetic patients who are treated with metformin with HBA1C>7% will get glibenclamide
 Drug: glibenclamide
glibenclamide 5 mg once a day titrated as neede up to 20 mg a day
Other Name: glibenclamide

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696982

Contacts
Contact: Shlomit Koren, MD 972-546-888-385 shlomitks@gmail.com
Contact: Shai Efrati, MD 972-577-346-364 efratishai@013.net

Locations
Israel
Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel Recruiting
Zrifin, Israel, 70300
Contact: Shlomit Koren, MD     972-546-888=385     shlomitks@gmail.com    
Contact: Shai Efrati, MD     972-577-346-364     efratishai@013.net    
Principal Investigator: Shlomit Koren, MD            
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Shlomit Koren MD, Assaf-Harofeh Medical Center internal medicine A
ClinicalTrials.gov Identifier: NCT00696982     History of Changes
Other Study ID Numbers: shlomit9
Study First Received: June 11, 2008
Last Updated: June 12, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
Arterial stiffness
Augmentation index
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
 Sitagliptin
Glyburide
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 June 18, 2013