NCT05312892 Sympathetic Mechanisms in Obesity-Crossover Design
| NCT ID | NCT05312892 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-05-20 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2022-05-20 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Frequently Asked Questions
Who can join the NCT05312892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05312892 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05312892 currently recruiting?
Yes, NCT05312892 is actively recruiting participants. Visit ClinicalTrials.gov or contact Vanderbilt University Medical Center to inquire about joining.
Where is the NCT05312892 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05312892 clinical trial?
NCT05312892 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 12 participants.
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