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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01180231
• Other study ID #: Project 168-10
• Status: Recruiting
• Phase: Phase 4
• First received: August 10, 2010
• Last updated: November 3, 2013
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: November 2013
• Source: Baker IDI Heart and Diabetes Institute
• Contact: Elisabeth Lambert, PhD
• Phone: 03 8532 1345
• Email: elisabeth.lambert[@]bakeridi.edu.au
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Moxonidine (Physiotens)
Subjects will be asked to take moxonidine, dosage to be determined prior to commencement by a medical doctor for 6 months duration.

Other:
• Dietary intervention
Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.

Locations

Country	Name	City	State
Australia	BakerIDI Heart and Diabetes Institute	Prahran	Victoria
Australia	BakerIDI Heart and Diabetes Institute	Prahran	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Baker IDI Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No