Sympathetic Mechanisms in Obesity-Crossover Design
Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for adults with obesity and high blood pressure. It tests whether moxonidine, a drug that blocks certain nerve signals, improves how the body makes sugar. Each person will receive moxonidine, amlodipine (a drug that widens blood vessels), and a placebo (a treatment with no active drug) for two weeks each, in a randomly chosen order.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Adults ages 18 to 65, of any sex or race.
- High blood pressure: above 130/85 on at least two properly taken readings while seated, or currently taking blood pressure medicine.
- Obesity: a body mass index (BMI), a measure based on height and weight, of 30 or higher.
- Able and willing to give informed consent, meaning you understand and agree to join.
Who can't join
- Pregnant or breastfeeding.
- Currently smoking, a history of smoking more than two packs a day, or a history of alcohol or drug abuse.
- A past allergic reaction to study medicines, or type 1 diabetes.
- Certain heart or blood vessel problems besides high blood pressure, including a heart attack in the past six months, chest pain, major heartbeat problems, heart failure, certain valve or heart muscle problems, or blood clots in deep veins or the lungs. Thickening of the heart’s main pumping chamber is allowed.
- A history of serious brain blood vessel problems, such as bleeding in the brain, a stroke, or a mini-stroke.
- Past or current immune system or blood disorders, or poor kidney function.
- Taking steroid medicines that affect the whole body for more than seven days in a row in one month, or taking an experimental drug in the month before the study.
- Unable to give consent, withdrawing consent, or other issues the study doctor thinks would prevent completion, such as major exam or lab findings, trouble following study steps, or inability to place an IV line in a vein.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
TN
- Vanderbilt University Medical Center · Nashville, TN 37232Cynthia Laws, MS · Study contact · 615-421-1994 · autonomicgroup@vumc.orgAlfredo Gamboa, MD · Study contact · alfredo.gamboa@vumc.orgItalo Biaggioni, MD · Sub-investigatorMore trials in Nashville