Sympathetic Mechanisms in Obesity-Crossover Design

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Apr 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how certain medications might help people who are both obese and have high blood pressure (hypertension). Specifically, researchers want to see if a treatment that blocks the sympathetic nervous system can improve how the body produces glucose, which is important for energy. Participants in the study will receive one of three treatments—either a placebo (a "sugar pill"), a medication called amlodipine, or another medication called moxonidine—over two weeks. Participants won’t know which treatment they are receiving at any time, and the results will be analyzed by someone who also doesn’t know which treatment each participant got.

To be eligible for this trial, participants should be between 18 and 65 years old, have high blood pressure (with specific blood pressure readings), and be considered obese (with a body mass index of 30 or higher). There are some important exclusions, such as being pregnant, having certain heart or blood vessel diseases, or having a history of serious substance abuse. If you join the trial, you can expect to attend three visits over the course of the study, where you will receive the different treatments and undergo assessments to understand the effects. It's a chance to contribute to important research that could help improve treatments for obesity and hypertension.

Gender

ALL

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)