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

This study is currently recruiting participants.
Verified November 2013 by Baker IDI Heart and Diabetes Institute
Sponsor:
Information provided by:
Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier:
NCT01180231
First received: August 10, 2010
Last updated: November 3, 2013
Last verified: November 2013

August 10, 2010
November 3, 2013
September 2010
September 2014   (final data collection date for primary outcome measure)
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. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01180231 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Single Blind (Subject)
  • Obesity
  • Overweight
  • 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 Name: Physiotens
  • Other: Dietary intervention
    Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.
  • Active Comparator: Moxonidine
    Intervention: Drug: Moxonidine (Physiotens)
  • Active Comparator: Diet
    Intervention: Other: Dietary intervention
  • Active Comparator: Moxonidine and diet
    Subjects will be asked to take moxonidine and follow dietary plan designed by a qualified nutritionist for 6 months.
    Interventions:
    • Drug: Moxonidine (Physiotens)
    • Other: Dietary intervention
  • No Intervention: Control
    Subjects will not be asked to take any interventions.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
77
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Male
18 Years to 30 Years
No
Contact: Elisabeth Lambert, PhD 03 8532 1345 elisabeth.lambert@bakeridi.edu.au
Contact: Markus Schlaich, A/Prof 03 8532 1502 markus.schlaich@bakeridi.edu.au
Australia
 
NCT01180231
Project 168-10
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Dr Elisabeth Lambert, BakerIDI Heart and Diabetes Institute
Baker IDI Heart and Diabetes Institute
Not Provided
Not Provided
Baker IDI Heart and Diabetes Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP