Status:
COMPLETED
The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Diabetes Type 2
Eligibility:
All Genders
21-80 years
Phase:
NA
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 m...
Eligibility Criteria
Inclusion
- Group 1. Subjects At Risk of Developing Type 2 Diabetes
- INCLUSION CRITERIA
- Ages of 21-80 years
- 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
- Treatment with Aliskiren (Tekturna)
- Smokers (use of tobacco products in the previous 3 months)
- 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
- Liver Disease (AST, ALT, Alk Phos levels \> 2x UNL)
- 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
- Hyperkalemia (serum potassium \>5.0 meq/L)
- Severe Dyslipidemia (TG \> 600 mg/dL or Cholesterol \>350 mg/dL)
- Any Other Serious Chronic Disease Requiring Active Treatment
- Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators
- Pregnancy
- 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
- 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
- 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
- Ages of 21-80 years
- Type 2 Diabetes Mellitus stable and not expected to change during the study period
- EXCLUSION CRITERIA
- Treatment with Aliskiren (Tekturna)
- Smokers (use of tobacco products in the previous 3 months)
- 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
- Liver Disease (AST, ALT, Alk Phos levels \> 2x UNL)
- 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
- Hyperkalemia (serum potassium \>5.0 meq/L)
- Severe Dyslipidemia (TG \> 600 mg/dL or Cholesterol \>350 mg/dL)
- Any Other Serious Chronic Disease Requiring Active Treatment
- Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators
- Pregnancy
- 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
- 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
- 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
- Severe proliferative retinopathy that renders the subject legally blinded
- Previous diagnosis of severe gastroparesis diabeticorum due to autonomic neuropathy that has necessitated hospital admission
- Presence of non-healing foot ulceration due to severe peripheral diabetic neuropathy
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01165983
Start Date
November 1 2009
Last Update
March 28 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory
Boston, Massachusetts, United States, 02215