Vanderbilt Clinical Trials

Sympathetic Mechanisms in Obesity-Crossover Design

Purpose

We will study obese hypertensive subjects in a randomized, crossover study to determine if two weeks sympathetic blockade improves endogenous glucose production. Subjects will be studied on 3 different occasions after two weeks of receiving either placebo, amlodipine (vasodilator arm) or moxonidine (study arm). The order of the studies will be determined using computer-generated randomization. Patients will be blinded as to which treatment they are receiving on each day. An investigator blinded to the treatment assignment will perform the analysis of the data.

Conditions

Obesity
Hypertension

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 65 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 - Type I diabetes. - Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy - History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack - History or presence of immunological or hematological disorders - Impaired renal function - Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month) - 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 (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol, inability to find IV access)

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Basic Science
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Placebo	Subjects will received 2 weeks of capsules containing placebo.	Drug: Placebo Placebo
Active Comparator Amlodipine	Subjects will received 2 weeks of capsules containing amlodipine.	Drug: Amlodipine Subjects will receive either an antihypertensive (amlodipine or moxonidine) medication or placebo for two weeks, then cross over to the second arm, and then after 2 weeks of the second drug/placebo, will be switched to the third arm. Other names: Antihypertensive
Experimental Moxonidine	Subjects will received 2 weeks of capsules containing moxonidine.	Drug: Moxonidine Moxonidine Other names: Antihypertensive

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Contact:
Cynthia Laws, MS
615-421-1994
autonomicgroup@vumc.org

More Details

Status: Recruiting
Sponsor: Vanderbilt University Medical Center

Study Contact

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.