Sympathetic Mechanisms in Obesity-Crossover Design

Obesity Clinical Trial

Official title:

Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312892
• Other study ID #: 212413
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 20, 2022
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Obesity

Intervention

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.
• Moxonidine
Moxonidine
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous glucose production	Rate of appearance and disappearance of labeled glucose	During two-step insulin clamp (six hours)