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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01180231




Registration number
NCT01180231
Ethics application status
Date submitted
10/08/2010
Date registered
12/08/2010
Date last updated
5/11/2013

Titles & IDs
Public title
Study of the Effect of Moxonidine and Diet on Sympathetic Functions in Young Adults With Obesity
Scientific title
Assessment of the Effect of Moxonidine and Diet on Cardiac, Renal and Endothelial Function in Young Subjects With Abdominal Obesity
Secondary ID [1] 0 0
Project 168-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Overweight 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Moxonidine (Physiotens)
Other interventions - Dietary intervention

Active comparator: Moxonidine -

Active comparator: Diet -

Active comparator: Moxonidine and diet - Subjects will be asked to take moxonidine and follow dietary plan designed by a qualified nutritionist for 6 months.

No intervention: Control - Subjects will not be asked to take any interventions.


Treatment: Drugs: 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 interventions: Dietary intervention
Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Males age between 18 to 30 years old
* Abdominal obesity according to International Diabetes Federation (IDF) definition
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Any medications
* history of cardiovascular disease
* history of diabetes
* history of psychiatric illness

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2014
Actual
Sample size
Target
77
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
BakerIDI Heart and Diabetes Institute - Prahran
Recruitment postcode(s) [1] 0 0
3004 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01180231
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elisabeth Lambert, PhD
Address 0 0
Country 0 0
Phone 0 0
03 8532 1345
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01180231