Recruiting
Sympathetic Mechanisms in Obesity-Crossover Design
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…
ClinicalTrials.gov IDNCT05312892
PhasePHASE1, PHASE2
Enrollment12
SponsorVanderbilt University Medical Center
Age18 Years
SexALL
Conditions studied
Obesity, Hypertension
About this study
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.
Interventions
- 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.
- Drug: Moxonidine — Moxonidine
- Drug: Placebo — Placebo
Primary outcomes
- Endogenous glucose production (During two-step insulin clamp (six hours))
Eligibility information
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 locations
- Vanderbilt University Medical Center, Nashville, Tennessee 37232 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.