Sympathetic Mechanisms in Obesity-Crossover Design

Phase 1

Recruiting

• Conditions: Obesity; Hypertension
• Interventions: Drug: Placebo; Drug: Moxonidine; Drug: Amlodipine

• Registration Number: NCT05312892
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-06
• Study Start: 2022-05-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will received 2 weeks of capsules containing placebo.
Moxonidine	Moxonidine	Subjects will received 2 weeks of capsules containing moxonidine.
Amlodipine	Amlodipine	Subjects will received 2 weeks of capsules containing amlodipine.

Primary Outcome Measures

Name	Time	Method
Endogenous glucose production	During two-step insulin clamp (six hours)	Rate of appearance and disappearance of labeled glucose

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States