ObesityPhase 4NCT01180231
Study of the Effect of Moxonidine and Diet on Sympathetic Functions in Young Adults With Obesity
A Phase 4 study testing Moxonidine (Physiotens) and Dietary intervention in people with Obesity and Overweight, run by Baker Heart and Diabetes Institute at 2 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Moxonidine (Physiotens) and Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesAustralia
- Study dates
- Sep 2010to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males age between 18 to 30 years old
- Abdominal obesity according to International Diabetes Federation (IDF) definition
Who cannot join
- Any medications
- history of cardiovascular disease
- history of diabetes
- history of psychiatric illness
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Not yet recruiting
BakerIDI Heart and Diabetes Institute
Prahran, Victoria, 3004
Elisabeth Lambert, PhD, 03 8532 1345, elisabeth.lambert@bakeridi.edu.au
- Recruiting
BakerIDI Heart and Diabetes Institute
Prahran, Victoria, 3004
Carolina Sari, BSci (Hons.), 03 8532 1163, carolina.ikasari@bakeridi.edu.au
About this study
Official title: 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.
- Conditions
- Obesity, Overweight
- Being tested
- Moxonidine (Physiotens), Dietary intervention
- Keywords
- Overweight or obese young adults (18 to 30 years old) with no previous history of cardiovascular disease/psychiatric illness, and not on medications
- Medical subject headings
- Obesity, Overweight, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxonidine (Physiotens)Drug
Also called Physiotens
Subjects will be asked to take moxonidine, dosage to be determined prior to commencement by a medical doctor for 6 months duration.
Dietary interventionOther
Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Moxonidine | Active comparator | Not described Receives: Drug: Moxonidine (Physiotens) |
| Diet | Active comparator | Not described Receives: 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. Receives: Drug: Moxonidine (Physiotens); Other: Dietary intervention |
| Control | No intervention | Subjects will not be asked to take any interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180231
- Sponsor's protocol ID
- Project 168-10
- Status last verified
- Nov 2013
- First submitted
- 10 Aug 2010
- Last updated
- 5 Nov 2013
- Results posted
- No
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.
PubMed 28865109
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Moxonidine and Diet on Cardiac, Renal and Endothelial Function in Young Subjects With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT01180231
- Acronym / sponsor ID
- Project 168-10
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moxonidine | Active comparator | Drug: Moxonidine (Physiotens) |
| Diet | Active comparator | Other: Dietary intervention |
| Moxonidine and diet | Active comparator | Drug: Moxonidine (Physiotens), Other: Dietary interventionSubjects will be asked to take moxonidine and follow dietary plan designed by a qualified nutritionist for 6 months. |
| Control | No intervention | –Subjects will not be asked to take any interventions. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males age between 18 to 30 years old
- Abdominal obesity according to International Diabetes Federation (IDF) definition
Key exclusion criteria (4 listed)
- Any medications
- history of cardiovascular disease
- history of diabetes
- history of psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxonidine (Physiotens)Also: PhysiotensSubjects will be asked to take moxonidine, dosage to be determined prior to commencement by a medical doctor for 6 months duration. | Drug | Moxonidine, Moxonidine and diet |
| Dietary interventionSubjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months. | Other | Diet, Moxonidine and diet |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
- Derived from this study: PubMed 28865109Lambert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxonidine (Physiotens) and Dietary intervention in people with Obesity and Overweight, run by Baker Heart and Diabetes Institute at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Lambert, PhD (03 8532 1345, elisabeth.lambert@bakeridi.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.