Sympathetic Mechanisms in Obesity-Crossover Design

NCT05312892 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 212413
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Endogenous glucose production

  Rate of appearance and disappearance of labeled glucose

  During two-step insulin clamp (six hours)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects will received 2 weeks of capsules containing placebo.

Drug: Placebo

Amlodipine

ACTIVE COMPARATOR

Subjects will received 2 weeks of capsules containing amlodipine.

Drug: Amlodipine

Moxonidine

EXPERIMENTAL

Subjects will received 2 weeks of capsules containing moxonidine.

Drug: Moxonidine

Interventions

Amlodipine 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.

Also known as: Antihypertensive

Amlodipine

Moxonidine DRUG

Moxonidine

Also known as: Antihypertensive

Moxonidine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Hypertension

Interventions

Amlodipine; Antihypertensive Agents; moxonidine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 6, 2022
• Study Start: May 20, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)