Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05312892

Conditions

Obesity

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Amlodipine

Moxonidine

Placebo

Study Details

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 ID

NCT05312892

Start date

May 20, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Subjects will received 2 weeks of capsules containing placebo.

active comparator: Amlodipine

Subjects will received 2 weeks of capsules containing amlodipine.

experimental: Moxonidine

Subjects will received 2 weeks of capsules containing 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.

Moxonidine

Moxonidine

Placebo

Placebo

Primary outcome measure

  • Endogenous glucose production [ Time Frame: During two-step insulin clamp (six hours) ]

Central Contacts and Locations

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Cynthia Laws, MS

615-421-1994autonomicgroup@vumc.org

Alfredo Gamboa, MD

alfredo.gamboa@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-02-27.