Status:
TERMINATED
Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Insulin Sensitivity
Aortic Compliance
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is an investigation of the effect of commonly prescribed anti-hypertensive agents on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are as follows: Sp...
Eligibility Criteria
Inclusion
- Men and women, 18-70 years old
- BMI =/\< 35
- BP: BP \> 145/95 on no BP medication or on 3 or less BP medications
- HOMA =\>2.5
- Any race
Exclusion
- 4 or more BP medications
- Intolerance or known prior adverse history from taking the medications amlodipine, aliskiren or valsartan
- BP \>170/110 on screening exam
- Alcohol intake \>12 oz per week
- Current smoking
- Recreational drug use
- Known or suspected secondary hypertension
- Known history of coronary artery disease, cerebrovascular disease or congestive heart failure
- History or known kidney disease (eGFR \<50cc/min)
- Diabetes or current metformin use, or HbA1c \>=6.5% on screen
- Steroid use (oral or inhaled, chronic or within the past 6 months)
- Clinically significant screening lab abnormalities (See attached "Screening Labs Acceptable Ranges")
- Evidence of ischemia or heart block on screening electrocardiogram (greater than type I-second degree heart block, left bundle branch block, or ST-T wave changes in 2 or more contiguous leads).
- Acute hospitalizations including surgery in the past 6 months
- Chronic use of non-steroidal anti-inflammatory or narcotic medications
- Women who are pregnant or nursing, or wish to become pregnant and/or who can not agree or tolerate two forms of birth control during the study period:
- Acceptable birth control methods for use in this study are:
- hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
- barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- intrauterine device (IUD)
- abstinence (no sex)
- Significant concomitant medical illnesses (cancer, chronic active immunological conditions, etc.)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01252238
Start Date
June 1 2010
End Date
December 1 2012
Last Update
February 13 2018
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115