Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity
Purpose
The purpose of this study is to study the role of sympathetic mechanisms involved in chronic regulation of cardiovascular and metabolic abnormalities seen in obesity. We will study the effects chronic sympathetic inhibition on insulin sensitivity, inflammation and endothelial function in obese hypertensive human subjects.
Condition
- Obesity-Associated Insulin Resistance
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Males and females of all races between 18 and 60 years of age - Hypertension defined by two or more properly measured seated blood pressure readings >130/85 mmHg or currently on antihypertensive medication. - Obesity will be defined as having a body mass index (BMI) ≥ 30 kg/m2. - Able and willing to provide informed consent.
Exclusion Criteria
- Pregnancy or breast feeding - Current smokers or history of heavy smoking (>2 packs/day) - History of alcohol or drug abuse - Previous allergic reaction to study medications - Evidence of type I diabetes - Cardiovascular disease other than hypertension - History of serious cerebrovascular disease - History or presence of immunological or hematological disorders - Impaired renal function - Treatment with any investigational drug in the 1 month preceding the study - Inability to give, or withdraw, informed consent - Other factors which in the investigator's opinion would prevent the subject from completing the protocol
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Moxonidine |
Moxonidine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks |
|
Active Comparator Valsartan |
Valsartan to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks |
|
Active Comparator Amlodipine |
Amlodipine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks |
|
Recruiting Locations
Vanderbilt University
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Italo Biaggioni