Vanderbilt Clinical Trials

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	Drug: Moxonidine We will measure insulin sensitivity at baseline and after 9 weeks of treatment
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	Drug: Moxonidine We will measure insulin sensitivity at baseline and after 9 weeks of treatment
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	Drug: Moxonidine We will measure insulin sensitivity at baseline and after 9 weeks of treatment

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37232

Contact:
Emily C Smith, RN
615-875-1516
autonomics@vumc.org

More Details

Status: Recruiting
Sponsor: Italo Biaggioni

Study Contact

Emily C Smith, RN
615-875-1516
autonomics@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.