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

NCT01180231 | Unknown Phase 4

• 1 other identifier: Project 168-10
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (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.

Study Arms (4)

Moxonidine

ACTIVE COMPARATOR

Drug: Moxonidine (Physiotens)

Diet

ACTIVE COMPARATOR

Other: Dietary intervention

Moxonidine and diet

ACTIVE COMPARATOR

Subjects will be asked to take moxonidine and follow dietary plan designed by a qualified nutritionist for 6 months.

Drug: Moxonidine (Physiotens); Other: Dietary intervention

Control

NO INTERVENTION

Subjects will not be asked to take any interventions.

Interventions

Moxonidine (Physiotens) DRUG

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

Also known as: Physiotens

Moxonidine; Moxonidine and diet

Dietary intervention OTHER

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

Diet; Moxonidine and diet

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males age between 18 to 30 years old
• Abdominal obesity according to International Diabetes Federation (IDF) definition

You may not qualify if:

• Any medications
• history of cardiovascular disease
• history of diabetes
• history of psychiatric illness

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

Study Sites (2)

BakerIDI Heart and Diabetes Institute

Prahran, Victoria, 3004, Australia

NOT YET RECRUITING

BakerIDI Heart and Diabetes Institute

Prahran, Victoria, 3004, Australia

RECRUITING

Related Publications (1)

• Lambert EA, Sari CI, Eikelis N, Phillips SE, Grima M, Straznicky NE, Dixon JB, Esler M, Schlaich MP, Head GA, Lambert GW. Effects of Moxonidine and Low-Calorie Diet: Cardiometabolic Benefits from Combination of Both Therapies. Obesity (Silver Spring). 2017 Nov;25(11):1894-1902. doi: 10.1002/oby.21962. Epub 2017 Sep 2.

  PMID: 28865109 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Mental Disorders

Interventions

moxonidine; Diet Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Elisabeth Lambert, PhD

CONTACT

03 8532 1345; elisabeth.lambert@bakeridi.edu.au

Markus Schlaich, A/Prof

CONTACT

03 8532 1502; markus.schlaich@bakeridi.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 12, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

AU (2)