Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
Recruitment status was Active, not recruiting
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| First Received Date ICMJE | May 11, 2011 | ||||||||
| Last Updated Date | May 11, 2011 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Cardiovascular Disease Risk Factors [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ] Inflammation as determined by C-Reactive Protein and Cardiac Structure and Function as defined by left ventricular mass, aortic pulse wave velocity, fibrosis, and ejection fraction. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Weight Loss [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ] Weight loss by diet alone, diet plus aerobic training, and diet plus resistance training. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women | ||||||||
| Official Title ICMJE | The Effect of Weight Loss and Exercise on Cardiovascular Disease Risk Factors in Class II and III Obese Women | ||||||||
| Brief Summary | The purpose of this study is to examine the effect of weight loss and exercise on cardiovascular disease risk factors, specifically inflammation as measured by C-Reactive Protein and cardiac structure and function as measured by cardiac MRI, in Class II and III obese women during a 12 week training intervention. |
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| Detailed Description | To date, research investigating obesity, inflammation, and cardiovascular disease has utilized lifestyle interventions focused on weight loss and exercise among groups with BMI classifications of normal, overweight and mildly obese. A limitation of recent investigations is the failure to utilize participants who are significantly overweight. Those whose BMI classification extends to Class II and Class III obesity (BMI > 35.0, and BMI > 40.0) have not yet been studied at length, yet these individuals have been shown to be able to substantially improve their cardiovascular risk profiles without attaining a BMI below 25. Inactivity has been linked to increased adiposity and a trend toward higher levels of cardiovascular disease risk. It is necessary to study the relationships between weight loss and weight loss with added physical activity among Class II and Class III obese participants in order to gain a more thorough knowledge of the effects of BMI on circulating markers of inflammation and the cardiac structural and functional changes associated with weight loss among this population. A second limitation of the current research is the use of strictly progressive resistance training protocols. The protocols used have increased constantly in intensity or volume, if not both. Constant increases in intensity tend to lead to overtraining among participants, highlighting a need for more variation of intensity and volume in the training protocol in order to avoid stagnation and overtraining. Finally, no research has studied the specific impact of diet and resistance training on either CRP or cardiovascular adaptations. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | July 2011 | ||||||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 30 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01353001 | ||||||||
| Other Study ID Numbers ICMJE | BSD-UPitt | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Steven D. Verba/Graduate Student Researcher, University of Pittsburgh | ||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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