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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01165983
First received: December 15, 2009
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention
Diabetes Type 2
Drug: Placebo
Drug: Aliskiren

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Flow Mediated Vasodilation [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Nitroglycerine Induced Vasodilation [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Skin blood flow before and after iontophoresis with Acetylcholine and Sodium Nitroprusside [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical Markers of Endothelial Function [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Inflammatory Cytokines and Growth Factors [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Skin expression of Endothelial Nitric Oxide Synthase (eNOS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: November 2009
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165983

Locations
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
Principal Investigator: Aristidis Veves, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01165983     History of Changes
Other Study ID Numbers: 2009P-000233
Study First Received: December 15, 2009
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on August 28, 2014