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

Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Type 2

Intervention: Placebo (Drug); Aliskiren (Drug)

Phase: N/A

Status: Completed

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Aristidis Veves, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome:

Flow Mediated Vasodilation

Flow Mediated Vasodilation

Nitroglycerin Induced Dilation

Nitroglycerine Induced Vasodilation

Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside

Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside

Secondary outcome:

Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL

Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL

Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL

Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL

Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL

Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL

Eligibility

Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory, Boston, Massachusetts 02215, United States
Additional Information

Starting date: November 2009
Last updated: January 26, 2015

Page last updated: August 23, 2015

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