Sympathetic Mechanisms in Obesity-Crossover Design

Vanderbilt University Medical Center

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hypertension; Obesity

Treatments: Drug: Amlodipine; Drug: Placebo; Drug: Moxonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05312892

212413

Details and patient eligibility

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will received 2 weeks of capsules containing placebo.

Treatment:

Drug: Placebo

Amlodipine

Active Comparator group

Description:

Subjects will received 2 weeks of capsules containing amlodipine.

Treatment:

Drug: Amlodipine

Moxonidine

Experimental group

Description:

Subjects will received 2 weeks of capsules containing moxonidine.

Treatment:

Drug: Moxonidine