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The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes

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ClinicalTrials.gov Identifier: NCT01165983
Recruitment Status : Completed
First Posted : July 20, 2010
Results First Posted : February 9, 2015
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Aristidis Veves, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
The purpose of this research is to study and determine the effects of Aliskiren on blood vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial function by 30% or more in comparison to the placebo group.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Drug: Placebo Drug: Aliskiren Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes
Study Start Date : November 2009
Actual Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
Drug Information available for: Aliskiren

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
0mg tablet, taken orally for 12 weeks daily
Experimental: Aliskiren Drug: Aliskiren
150mg tablet, taken orally for 12 weeks daily
Other Name: Trade name: Tekturna


Outcome Measures
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Primary Outcome Measures :
  1. Flow Mediated Vasodilation [ Time Frame: Baseline ]
    Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.

  2. Flow Mediated Vasodilation [ Time Frame: 12 Weeks post-randomization ]
    Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.

  3. Nitroglycerin Induced Dilation [ Time Frame: Baseline ]
    Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.

  4. Nitroglycerine Induced Vasodilation [ Time Frame: 12 Weeks post-randomization ]
    Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.

  5. Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside [ Time Frame: Baseline ]
    Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.

  6. Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside [ Time Frame: 12 Weeks post-randomization ]
    Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).


Secondary Outcome Measures :
  1. Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL [ Time Frame: 12 Weeks post-randomization ]
  2. Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL [ Time Frame: 12 Weeks post-randomization ]
  3. Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL [ Time Frame: 12 Weeks post-randomization ]
  4. Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL [ Time Frame: 12 Weeks post-randomization ]
  5. Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL [ Time Frame: 12 Weeks post-randomization ]
  6. Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL [ Time Frame: 12 Weeks post-randomization ]
  7. Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL [ Time Frame: 12 Weeks post-randomization ]
  8. Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL [ Time Frame: 12 Weeks post-randomization ]
  9. Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL [ Time Frame: 12 Weeks post-randomization ]
  10. Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL [ Time Frame: 12 Weeks post-randomization ]
  11. Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL [ Time Frame: 12 Weeks post-randomization ]
  12. Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL [ Time Frame: 12 Weeks post-randomization ]
  13. Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL [ Time Frame: 12 Weeks post-randomization ]
  14. Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL [ Time Frame: 12 Weeks post-randomization ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Group 1. Subjects At Risk of Developing Type 2 Diabetes

INCLUSION CRITERIA

  1. Ages of 21-80 years
  2. Subjects "at risk" of developing type 2 Diabetes Mellitus (First degree relatives history of type 2 Diabetes Mellitus, History of gestational Diabetes, Known impaired glucose tolerance, Impaired fasting plasma glucose 100-126 mg/dl at the time of enrollment)

EXCLUSION CRITERIA

  1. Treatment with Aliskiren (Tekturna)
  2. Smokers (use of tobacco products in the previous 3 months)

  3. Active or Uncontrolled Cardiovascular Disease

    • Myocardial infarction, or angina within 12 months of study participation
    • Arrhythmia (uncontrolled, highly symptomatic, requiring treatment or life-threatening)
    • CHF (Class III and IV symptoms of heart failure on less than ordinary exertion or at rest)
    • Stroke or Transient Ischemic Attack (TIA) within 12 months of study participation
    • Uncontrolled Hypertension (SBP >180 mmHg or DBP >105 mmHg; 2 abnormal readings during visit)
    • History of previous hypotensive episodes
  4. Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)
  5. Renal Disease (creatinine > 1.7 mg/dL for women and >2.0 mg/dL for men and/or estimated GFR <30 mL/min, history of dialysis, nephrotic syndrome and known renovascular hypertension) at the time of enrollment
  6. Hyperkalemia (serum potassium >5.0 meq/L)
  7. Severe Dyslipidemia (TG > 600 mg/dL or Cholesterol >350 mg/dL)
  8. Any Other Serious Chronic Disease Requiring Active Treatment
  9. Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators
  10. Pregnancy

  11. Taking Any of the Following Medications:

    • Systemic (not inhaled) Glucocorticoids
    • Antineoplastic Agents
    • Cyclosporine, Ketoconazole, Furosemide, Warfarin
    • Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis
  12. Patient is known to have a history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result in the past
  13. History of drug or alcohol abuse within the 12months prior to dosing or evidence of such abuse as indicated by laboratory assays conducted during screening or baseline evaluations

Group 2. Type 2 Diabetic Patients

INCLUSION CRITERIA

  1. Ages of 21-80 years
  2. Type 2 Diabetes Mellitus stable and not expected to change during the study period

EXCLUSION CRITERIA

  1. Treatment with Aliskiren (Tekturna)
  2. Smokers (use of tobacco products in the previous 3 months)

  3. Active or Uncontrolled Cardiovascular Disease

    • Myocardial infarction, or angina within 12 months of study participation
    • Arrhythmia (uncontrolled, highly symptomatic, requiring treatment or life-threatening)
    • CHF (Class III and IV symptoms of heart failure on less than ordinary exertion or at rest)
    • Stroke or Transient Ischemic Attack (TIA) within 12 months of study participation
    • Uncontrolled Hypertension (SBP >180 mmHg or DBP >105 mmHg; 2 abnormal readings during visit)
    • History of previous hypotensive episodes
  4. Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)
  5. Renal Disease (creatinine > 1.7 mg/dL for women and >2.0 mg/dL for men and/or estimated GFR <30 mL/min, history of dialysis, nephrotic syndrome and known renovascular hypertension) at the time of enrollment
  6. Hyperkalemia (serum potassium >5.0 meq/L)
  7. Severe Dyslipidemia (TG > 600 mg/dL or Cholesterol >350 mg/dL)
  8. Any Other Serious Chronic Disease Requiring Active Treatment
  9. Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators
  10. Pregnancy

  11. Taking Any of the Following Medications:

    • Systemic (not inhaled) Glucocorticoids
    • Antineoplastic Agents
    • Cyclosporine, Ketoconazole, Furosemide, Warfarin
    • Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis
  12. Patient is known to have a history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result in the past
  13. History of drug or alcohol abuse within the 12months prior to dosing or evidence of such abuse as indicated by laboratory assays conducted during screening or baseline evaluations
  14. Severe proliferative retinopathy that renders the subject legally blinded
  15. Previous diagnosis of severe gastroparesis diabeticorum due to autonomic neuropathy that has necessitated hospital admission
  16. Presence of non-healing foot ulceration due to severe peripheral diabetic neuropathy
  17. Documented diabetic nephropathy manifested as macro-albuminuria, (2 of 3 urine specimens collected within a 3-6 month period with urine albumin>300 ug/mg creatinine
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165983


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Aristidis Veves, MD Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aristidis Veves, Rongxiang Xu, MD Professor of Surgery in the Field of Regenerative Therapeutics, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01165983    
Other Study ID Numbers: 2009P000233
First Posted: July 20, 2010    Key Record Dates
Results First Posted: February 9, 2015
Last Update Posted: March 28, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Diabetes Mellitus, Type 2
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases