Study of the Effect of Moxonidine and Diet on Sympathetic Functions in Young Adults With Obesity
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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 |
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01180231
| 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 |
| 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 | |
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:
|
Moxonidine Antihypertensive Agents Cardiovascular Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015