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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during two-step insulin clamp (six hours)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have high blood pressure or am on medication for it.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
856 Previous Clinical Trials
672,180 Total Patients Enrolled
35 Trials studying Obesity
6,869 Patients Enrolled for Obesity

Media Library

Obesity Research Study Groups: Placebo, Amlodipine, Moxonidine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to join this research endeavor?

"According to clinicaltrials.gov, this research endeavour is still recruiting participants; it has been available since May 20th 2022 and the latest updates were made on June 8th 2022."

Answered by AI

Does this research project accept participants under the age of thirty?

"This medical trial is open to individuals aged 18 through 65. By comparison, there are 253 trials available for minors and 1231 studies catered towards senior citizens."

Answered by AI

Do I fit the criteria to join this research endeavor?

"Individuals looking to join this study must have hypertension and a age between 18-65. The total amount of participants is capped at 12 people."

Answered by AI

What is the participant quota for this research project?

"Affirmative, the information posted on clinicaltrials.gov confirms that this medical trial is actively enrolling participants. It was first announced on May 20th 2022 and has been recently amended as of June 8th 2022. Currently, 12 individuals are needed to be recruited from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am frustrated with my health and I am trying to find ways to help me improve my well-being.
PatientReceived 1 prior treatment
Please allow me to be apart if this trial. I am currently obese and have neuropathy which makes it impossible to exercise. I have just lost all hope. This would mean everything to me!!!
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Sympathetic Mechanisms in Obesity-Crossover Design
Italo Biaggioni 2022. "Sympathetic Mechanisms in Obesity-Crossover Design". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05312892.
~8 spots leftby Dec 2027
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