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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxonidine | Active Comparator |
| |
| Diet | Active Comparator |
| |
| Moxonidine and diet | Active Comparator | Subjects 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BakerIDI Heart and Diabetes Institute | Not yet recruiting | Prahran | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28865109 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C043482 | moxonidine |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
| Dietary intervention | Other | Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months. |
|
| BakerIDI Heart and Diabetes Institute | Recruiting | Prahran | Victoria | 3004 | Australia |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |