Sympathetic Mechanisms in Obesity-Crossover Design
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Vanderbilt University Medical Center
- Study ID
- NCT05312892
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Amlodipine — DRUGSubjects 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 — DRUGMoxonidine
- Placebo — DRUGPlacebo
Study Details
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.
Key Dates
- Start date
- May 20, 2022
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Placebo Comparator: PlaceboSubjects will received 2 weeks of capsules containing placebo.
- Active Comparator: AmlodipineSubjects will received 2 weeks of capsules containing amlodipine.
- Experimental: MoxonidineSubjects will received 2 weeks of capsules containing moxonidine.
Primary Outcome Measure
Endogenous glucose production [ Time Frame: During two-step insulin clamp (six hours) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Alfredo Gamboa, MD Italo Biaggioni, MD (SUB_INVESTIGATOR) |
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