Sympathetic Mechanisms in Obesity-Crossover Design
Recruiting · NCT05312892 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanderbilt University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
2 locations listed across 1 US state.
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States