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 — DRUG
    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 — DRUG
    Moxonidine
  • Placebo — DRUG
    Placebo

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: 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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Cynthia Laws, MS
615-421-1994
Alfredo Gamboa, MD
Italo Biaggioni, MD (SUB_INVESTIGATOR)

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