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Sympathetic Mechanisms in Obesity-Crossover Design

Primary Purpose

Obesity, Hypertension

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amlodipine
Moxonidine
Placebo
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Amlodipine

Moxonidine

Arm Description

Subjects will received 2 weeks of capsules containing placebo.

Subjects will received 2 weeks of capsules containing amlodipine.

Subjects will received 2 weeks of capsules containing moxonidine.

Outcomes

Primary Outcome Measures

Endogenous glucose production
Rate of appearance and disappearance of labeled glucose

Secondary Outcome Measures

Full Information

First Posted
March 28, 2022
Last Updated
February 9, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05312892
Brief Title
Sympathetic Mechanisms in Obesity-Crossover Design
Official Title
Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypertension

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will received 2 weeks of capsules containing placebo.
Arm Title
Amlodipine
Arm Type
Active Comparator
Arm Description
Subjects will received 2 weeks of capsules containing amlodipine.
Arm Title
Moxonidine
Arm Type
Experimental
Arm Description
Subjects will received 2 weeks of capsules containing moxonidine.
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
Antihypertensive
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Moxonidine
Other Intervention Name(s)
Antihypertensive
Intervention Description
Moxonidine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Endogenous glucose production
Description
Rate of appearance and disappearance of labeled glucose
Time Frame
During two-step insulin clamp (six hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Laws, MS
Phone
615-421-1994
Email
autonomicgroup@vumc.org
First Name & Middle Initial & Last Name & Degree
Alfredo Gamboa, MD
Email
alfredo.gamboa@vumc.org
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sympathetic Mechanisms in Obesity-Crossover Design

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