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

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ClinicalTrials.gov Identifier: NCT01180231
Recruitment Status : Unknown
Verified November 2013 by Baker IDI Heart and Diabetes Institute.
Recruitment status was:  Recruiting
First Posted : August 12, 2010
Last Update Posted : November 5, 2013
Sponsor:
Information provided by:
Baker IDI Heart and Diabetes Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: Moxonidine (Physiotens) Other: Dietary intervention Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: Non-Randomized
Masking: Single (Participant)
Official Title: Assessment of the Effect of Moxonidine and Diet on Cardiac, Renal and Endothelial Function in Young Subjects With Abdominal Obesity
Study Start Date : September 2010
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Moxonidine 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
Active Comparator: Diet Other: Dietary intervention
Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.
Active Comparator: Moxonidine and diet
Subjects will be asked to take moxonidine and follow dietary plan designed by a qualified nutritionist for 6 months.
 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.
No Intervention: Control
Subjects will not be asked to take any interventions.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180231


Contacts
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

Locations
Australia, Victoria
BakerIDI Heart and Diabetes Institute Not yet recruiting
Prahran, Victoria, Australia, 3004
Contact: Elisabeth Lambert, PhD    03 8532 1345    elisabeth.lambert@bakeridi.edu.au   
BakerIDI Heart and Diabetes Institute Recruiting
Prahran, Victoria, Australia, 3004
Contact: Carolina Sari, BSci (Hons.)    03 8532 1163    carolina.ikasari@bakeridi.edu.au   
Sponsors and Collaborators
Baker IDI Heart and Diabetes Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Elisabeth Lambert, BakerIDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01180231     History of Changes
Other Study ID Numbers: Project 168-10
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

Keywords provided by Baker IDI Heart and Diabetes Institute:
Overweight or obese young adults (18 to 30 years old) with no previous history of cardiovascular disease/psychiatric illness, and not on medications

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Signs and Symptoms
Moxonidine
Antihypertensive Agents