Sympathetic Mechanisms in Obesity-Crossover Design

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05312892

Collaborator

(none)

Enrollment

Location

Arms

91.4

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Hypertension	Drug: Amlodipine Drug: Moxonidine Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study.

Actual Study Start Date :

May 20, 2022

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Subjects will received 2 weeks of capsules containing placebo.	Drug: Placebo Placebo
Active Comparator: Amlodipine Subjects will received 2 weeks of capsules containing amlodipine.	Drug: Amlodipine 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. Other Names: Antihypertensive
Experimental: Moxonidine Subjects will received 2 weeks of capsules containing moxonidine.	Drug: Moxonidine Moxonidine Other Names: Antihypertensive

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Subjects will received 2 weeks of capsules containing placebo.

Drug: Placebo

Placebo

Active Comparator: Amlodipine

Subjects will received 2 weeks of capsules containing amlodipine.

Drug: Amlodipine

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.

Other Names:

Antihypertensive

Experimental: Moxonidine

Subjects will received 2 weeks of capsules containing moxonidine.

Drug: Moxonidine

Moxonidine

Other Names:

Antihypertensive

Outcome Measures

Primary Outcome Measures

Endogenous glucose production [During two-step insulin clamp (six hours)]
Rate of appearance and disappearance of labeled glucose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Italo Biaggioni, Professor of Medicine, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT05312892

Other Study ID Numbers:

212413

First Posted:

Apr 6, 2022

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Amlodipine

Antihypertensive Agents

Moxonidine

Study Results

No Results Posted as of Jun 9, 2022