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

Assessment of the Effect of Moxonidine and Diet on Cardiac, Renal and Endothelial Function in Young Subjects With Abdominal Obesity

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01180231
Enrollment
77
Registered
2010-08-12
Start date
2010-09-30
Completion date
2014-09-30
Last updated
2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

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

Brief summary

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.

Interventions

DRUGMoxonidine (Physiotens)

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

OTHERDietary intervention

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

Sponsors

Baker Heart and Diabetes Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To determine whether moxonidine is able to reverse the early organ damage compared to the effect of weight loss alone, and whether the addition of moxonidine during a weight loss program confers greater beneficial effect.

Countries

Australia

Contacts

Primary ContactElisabeth Lambert, PhD
elisabeth.lambert@bakeridi.edu.au03 8532 1345
Backup ContactMarkus Schlaich, A/Prof
markus.schlaich@bakeridi.edu.au03 8532 1502

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026