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Calcium Channel Blocker

Sympathetic Blockade for Obesity

Phase 1 & 2
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hypertension defined by two or more properly measured seated blood pressure readings >130/85 mmHg or currently on antihypertensive medication
Be older than 18 years old
Must not have
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
Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during two-step insulin clamp (six hours)

Summary

This trial will study whether or not two weeks of sympathetic blockade can improve endogenous glucose production in obese hypertensive subjects.

Who is the study for?
This trial is for men and women aged 18-65 with obesity (BMI ≥ 30 kg/m2) and high blood pressure (>130/85 mmHg or on medication). Participants must be able to consent. Exclusions include immunological/hematological disorders, allergies to study meds, impaired kidney function, Type I diabetes, serious cerebrovascular disease, heavy smoking, substance abuse, certain cardiovascular diseases.
What is being tested?
The study tests if sympathetic blockade by moxonidine improves glucose production in obese hypertensive subjects compared to amlodipine and placebo. It's a randomized crossover trial where patients receive each treatment for two weeks with random order and are blinded to the treatments.
What are the potential side effects?
Possible side effects of moxonidine may include dry mouth, drowsiness or fatigue; while amlodipine might cause swelling in the legs or ankles, flushing and palpitations. Placebo typically has no active ingredients but can lead to perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have high blood pressure or am on medication for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a heart attack or serious heart issues in the last 6 months.
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I have been on long-term steroid treatment for more than a week in the past month.
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I have a history of immune or blood disorders.
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I am unable to understand or decide about participating in this study.
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I have Type I diabetes.
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I have had a serious stroke or similar condition.
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I am a current smoker or have a history of heavy smoking.
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My kidneys are not working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during two-step insulin clamp (six hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during two-step insulin clamp (six hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Endogenous glucose production

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: MoxonidineExperimental Treatment1 Intervention
Subjects will received 2 weeks of capsules containing moxonidine.
Group II: AmlodipineActive Control1 Intervention
Subjects will received 2 weeks of capsules containing amlodipine.
Group III: PlaceboPlacebo Group1 Intervention
Subjects will received 2 weeks of capsules containing placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moxonidine
2011
Completed Phase 4
~480

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
908 Previous Clinical Trials
934,575 Total Patients Enrolled
39 Trials studying Obesity
8,635 Patients Enrolled for Obesity

Media Library

Obesity Research Study Groups: Placebo, Amlodipine, Moxonidine
~6 spots leftby Dec 2027
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