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Weight Loss Effects on Heart and Blood Vessel Function in Obesity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by University of Adelaide.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782262
First Posted: October 31, 2008
Last Update Posted: October 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Royal Adelaide Hospital
Information provided by:
University of Adelaide
  Purpose

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.


Condition Intervention Phase
Obesity Dietary Supplement: KicStart™ Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Obesity and Diet Induced Weight Loss on Cardiovascular Risk Factors, Vascular and Ventricular Structure and Function in Obese Men

Resource links provided by NLM:


Further study details as provided by University of Adelaide:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2005
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1 (n=20)
BP < 140/90, no diabetes mellitus and fasting glucose < 5.5
Dietary Supplement: KicStart™
KicStart™ is a nutritionally complete, but lower energy formulated liquid meal. Two sachets of KicStart™ (one for breakfast and one for lunch) provides 450 cal of energy per day, 0.8 grams per kilogram ideal body weight of high quality protein, and the recommended daily allowances (RDI) of minerals, vitamins, trace elements, omega 3 and 6 essential fatty acids. The Kicstart is supplemented with some salads, carbohydrate free vegetables and a small piece of meat fish or chicken each day in order to achieve a total energy intake of approximately 850 kcals/day.
Group 2 (n=20)
BP > 140/100, no diabetes mellitus and fasting glucose < 5.5
Dietary Supplement: KicStart™
KicStart™ is a nutritionally complete, but lower energy formulated liquid meal. Two sachets of KicStart™ (one for breakfast and one for lunch) provides 450 cal of energy per day, 0.8 grams per kilogram ideal body weight of high quality protein, and the recommended daily allowances (RDI) of minerals, vitamins, trace elements, omega 3 and 6 essential fatty acids. The Kicstart is supplemented with some salads, carbohydrate free vegetables and a small piece of meat fish or chicken each day in order to achieve a total energy intake of approximately 850 kcals/day.
Group 3 (n=20)
BP <140/100, no diabetes mellitus, fasting glucose 5.5 - 6.9
Dietary Supplement: KicStart™
KicStart™ is a nutritionally complete, but lower energy formulated liquid meal. Two sachets of KicStart™ (one for breakfast and one for lunch) provides 450 cal of energy per day, 0.8 grams per kilogram ideal body weight of high quality protein, and the recommended daily allowances (RDI) of minerals, vitamins, trace elements, omega 3 and 6 essential fatty acids. The Kicstart is supplemented with some salads, carbohydrate free vegetables and a small piece of meat fish or chicken each day in order to achieve a total energy intake of approximately 850 kcals/day.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782262


Contacts
Contact: Cynthia Piantadosi, PhD 61 8 82222473 cynthia.piantadosi@adelaide.edu.au

Locations
Australia, South Australia
University of Adelaide, Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Gary Wittert, MD, MB Bch, FRACP    +61 8 8222.5502    gary.wittert@adelaide.edu.au   
Principal Investigator: Cynthia Piantadosi, PhD         
Sponsors and Collaborators
University of Adelaide
Royal Adelaide Hospital
  More Information

Responsible Party: Dr Cynthia Piantadosi, University of Adelaide and Royal Adelaide Hospital
ClinicalTrials.gov Identifier: NCT00782262     History of Changes
Other Study ID Numbers: 050226
First Submitted: October 28, 2008
First Posted: October 31, 2008
Last Update Posted: October 31, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes


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