Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity

NCT04329806 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 190479R01HL149386
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the role of sympathetic mechanisms involved in chronic regulation of cardiovascular and metabolic abnormalities seen in obesity. The investigators will study the effects chronic sympathetic inhibition on insulin sensitivity, inflammation and endothelial function in obese hypertensive human subjects.

Conditions

Obesity-Associated Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Dose response curve to insulin (measure as glucose infusion rate, mg/kg/min)

  6 hours

Study Arms (2)

Moxonidine

EXPERIMENTAL

Moxonidine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks

Drug: Moxonidine 0.2 MG

Amlodipine

ACTIVE COMPARATOR

Amlodipine to be administered at a dose to produce a decrease in BP of at least 20% of baseline for 9 weeks

Drug: Amlodipine 5 MG

Interventions

Moxonidine 0.2 MG DRUG

Moxonidine 0.2 MG twice daily

Moxonidine

Amlodipine 5 MG DRUG

Amlodipine 5 MG twice daily

Amlodipine

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 60 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
• Evidence of type I diabetes
• Cardiovascular disease other than hypertension
• History of serious cerebrovascular disease
• History or presence of immunological or hematological disorders
• Impaired renal function
• 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

Sponsors & Collaborators

• Italo Biaggioni: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

moxonidine; Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Alfredo Gamboa
• Organization: Vanderbilt University Medical Center

alfredo.gamboa@vumc.org

615 875 1003

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: April 1, 2020
• Study Start: February 23, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: September 5, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-08

Locations

US (1)