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

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetes Type 2

In brief

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.

Key facts

Study ID

NCT01165983

Run by

Beth Israel Deaconess Medical Center

People needed

124

Starts

2009-11-01

Last updated by the study team

2017-03-28

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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