Sympathetic Mechanisms in Obesity-Crossover Design

NCT ID: NCT05312892

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2029-12-31

Brief 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.

Conditions

Obesity; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Subjects will received 2 weeks of capsules containing placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Amlodipine

Subjects will received 2 weeks of capsules containing amlodipine.

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

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

Subjects will received 2 weeks of capsules containing moxonidine.

Group Type: EXPERIMENTAL

Moxonidine

Intervention Type: DRUG

Moxonidine

Interventions

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.

Intervention Type: DRUG

Moxonidine

Moxonidine

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Antihypertensive; Antihypertensive

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Italo Biaggioni

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Cynthia Laws, MS

Role: primary

autonomicgroup@vumc.org

615-421-1994

Alfredo Gamboa, MD

Role: backup

alfredo.gamboa@vumc.org

Other Identifiers

212413

Identifier Type: -

Identifier Source: org_study_id