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Clinical Trials/NCT00782262
NCT00782262
Unknown
Phase 2

Effects of Obesity and Diet Induced Weight Loss on Cardiovascular Risk Factors, Vascular and Ventricular Structure and Function in Obese Men

University of Adelaide1 site in 1 country60 target enrollmentApril 2005
ConditionsObesity

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Adelaide
Enrollment
60
Locations
1
Primary Endpoint
This will be the first analysis of the impact of rapid aggressive weight loss in obese individuals on both short and long-term cardiovascular indices.
Last Updated
17 years ago

Overview

Brief Summary

Obesity is a growing epidemic and is associated with an increased risk of heart attack and stroke. The investigators know that obesity leads to abnormalities in how the blood vessels and the heart function and that these abnormalities are an important cause of this increased risk in obese individuals. While improvements in these abnormalities have been reported with marked weight reduction (eg surgery) and lifestyle changes including exercise training, it is not clear that these abnormalities can be substantially reversed with standard dietary interventions. Additional information is needed regarding the degree of weight loss required, the time course of these improvements, nor the mechanisms. All of these have major implications for the potential role of weight loss in the management of these patients.

The investigators will assess the effects of dietary induced weight loss in both the short and long term on the function of blood vessels and the heart, and the relationship of any changes with markers of inflammation that are present in obesity.

By understanding the factors that are important in reversing these abnormalities in obesity the investigators will be better to identify and reduce heart attack and stroke in obese individuals in the future.

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
January 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • Obese Caucasian men age 18-65 years, who are non smokers, and consuming 2 or fewer standard alcoholic drinks per day (on average over the past 5 years) will be recruited.
  • Obesity, for the purposes of this study, is defined by a BMI \> 30 and a waist circumference \> 102 cm.
  • Caucasian men only are enrolled because the cut-off points for the definition of obesity vary significantly by race.

Exclusion Criteria

  • Men are excluded if they have any previously diagnoses or symptomatic atherosclerotic disease, or are taking any cardiovascular medication.
  • Men with known gallstones, history of gout, or any contraindication to MRI are also excluded.

Outcomes

Primary Outcomes

This will be the first analysis of the impact of rapid aggressive weight loss in obese individuals on both short and long-term cardiovascular indices.

Time Frame: 4 years

Study Sites (1)

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