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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Obesity
Overweight
Drug: Moxonidine (Physiotens)
Other: Dietary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Single Blind (Subject)
Official Title: Assessment of the Effect of Moxonidine and Diet on Cardiac, Renal and Endothelial Function in Young Subjects With Abdominal Obesity

Resource links provided by NLM:


Further study details as provided by Baker IDI Heart and Diabetes Institute:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 77
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Elisabeth Lambert, BakerIDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01180231     History of Changes
Other Study ID Numbers: Project 168-10
Study First Received: August 10, 2010
Last Updated: November 3, 2013
Health Authority: Australia: Therapeutic Goods Administration

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
Obesity, Abdominal
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Moxonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014