Study of the Effect of Moxonidine and Diet on Sympathetic Functions in Young Adults With Obesity

NCT ID: NCT01180231

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-09-30

Brief Summary

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The prevalence of obesity is increasing rapidly among adults and has more than doubled in the past 10 years. The metabolic syndrome (MS) is often associated with obesity. It is characterized by abdominal obesity, high blood pressure, unfavorable blood cholesterol profile, elevated blood sugar and impaired insulin action. Persons with the MS have an increased risk of developing type 2 diabetes as well as heart and kidney disease.

The prevalence of obesity and MS is also very high in children and young adults. While there are increasing numbers of studies assessing risk factors for cardiovascular and kidney disease in middle aged to older obese subjects, few studies have addressed the issue of the presence of obesity in young adults and its association with MS on early damage to the organs such as the kidneys, the heart and the blood vessels. The investigators' laboratory has a particular interest on the sympathetic nervous system, which is an important regulatory mechanism of both metabolic and cardiovascular function, as altered sympathetic activity may play a role in the complications of obesity.

Moxonidine is a medication that is approved in Australia by the Therapeutic Goods Administration to treat high blood pressure. It works by decreasing the activity of the sympathetic nervous system. With the elevation of the sympathetic activity in obesity, the investigators believe moxonidine may have a favourable role in rescuing early organ damage associated with obesity. This study will assess whether treating obese subjects with moxonidine have positive effects on blood vessels, cardiac and kidney function and anxiety disorder. The investigators will also examine the influence of the sympathetic nervous system activity in these possible altered cardiac, kidney and vessel functions.

Detailed Description

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Conditions

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Obesity Overweight

Keywords

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Overweight or obese young adults (18 to 30 years old) with no previous history of cardiovascular disease/psychiatric illness, and not on medications

Study Design

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Allocation Method

NON_RANDOMIZED

Blinding Strategy

SINGLE

Participants

Study Groups

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Moxonidine

Group Type ACTIVE_COMPARATOR

Moxonidine (Physiotens)

Intervention Type DRUG

Subjects will be asked to take moxonidine, dosage to be determined prior to commencement by a medical doctor for 6 months duration.

Diet

Group Type ACTIVE_COMPARATOR

Dietary intervention

Intervention Type OTHER

Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.

Moxonidine and diet

Subjects will be asked to take moxonidine and follow dietary plan designed by a qualified nutritionist for 6 months.

Group Type ACTIVE_COMPARATOR

Moxonidine (Physiotens)

Intervention Type DRUG

Subjects will be asked to take moxonidine, dosage to be determined prior to commencement by a medical doctor for 6 months duration.

Dietary intervention

Intervention Type OTHER

Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.

Control

Subjects will not be asked to take any interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Moxonidine (Physiotens)

Subjects will be asked to take moxonidine, dosage to be determined prior to commencement by a medical doctor for 6 months duration.

Intervention Type DRUG

Dietary intervention

Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.

Intervention Type OTHER

Other Intervention Names

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Physiotens

Eligibility Criteria

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Inclusion Criteria

* Males age between 18 to 30 years old
* Abdominal obesity according to International Diabetes Federation (IDF) definition

Exclusion Criteria

* Any medications
* history of cardiovascular disease
* history of diabetes
* history of psychiatric illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Baker Heart and Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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BakerIDI Heart and Diabetes Institute

Locations

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BakerIDI Heart and Diabetes Institute

Prahran, Victoria, Australia

Site Status NOT_YET_RECRUITING

BakerIDI Heart and Diabetes Institute

Prahran, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Elisabeth Lambert, PhD

Role: CONTACT

Phone: 03 8532 1345

Email: [email protected]

Markus Schlaich, A/Prof

Role: CONTACT

Phone: 03 8532 1502

Email: [email protected]

Facility Contacts

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Elisabeth Lambert, PhD

Role: primary

Carolina Sari, BSci (Hons.)

Role: primary

References

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Lambert EA, Sari CI, Eikelis N, Phillips SE, Grima M, Straznicky NE, Dixon JB, Esler M, Schlaich MP, Head GA, Lambert GW. Effects of Moxonidine and Low-Calorie Diet: Cardiometabolic Benefits from Combination of Both Therapies. Obesity (Silver Spring). 2017 Nov;25(11):1894-1902. doi: 10.1002/oby.21962. Epub 2017 Sep 2.

Reference Type DERIVED
PMID: 28865109 (View on PubMed)

Other Identifiers

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Project 168-10

Identifier Type: -

Identifier Source: org_study_id