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Weight Loss Effects on Heart and Blood Vessel Function in Obesity

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
KicStart™
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Adelaide, Royal Adelaide HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Group 1 (n=20)

Group 2 (n=20)

Group 3 (n=20)

Arm Description

BP < 140/90, no diabetes mellitus and fasting glucose < 5.5

BP > 140/100, no diabetes mellitus and fasting glucose < 5.5

BP <140/100, no diabetes mellitus, fasting glucose 5.5 - 6.9

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2008
Last Updated
October 29, 2008
Sponsor
University of Adelaide
Collaborators
Royal Adelaide Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00782262
Brief Title
Weight Loss Effects on Heart and Blood Vessel Function in Obesity
Official Title
Effects of Obesity and Diet Induced Weight Loss on Cardiovascular Risk Factors, Vascular and Ventricular Structure and Function in Obese Men
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Adelaide
Collaborators
Royal Adelaide Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (n=20)
Arm Type
Other
Arm Description
BP < 140/90, no diabetes mellitus and fasting glucose < 5.5
Arm Title
Group 2 (n=20)
Arm Type
Other
Arm Description
BP > 140/100, no diabetes mellitus and fasting glucose < 5.5
Arm Title
Group 3 (n=20)
Arm Type
Other
Arm Description
BP <140/100, no diabetes mellitus, fasting glucose 5.5 - 6.9
Intervention Type
Dietary Supplement
Intervention Name(s)
KicStart™
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Piantadosi, PhD
Phone
61 8 82222473
Email
cynthia.piantadosi@adelaide.edu.au
Facility Information:
Facility Name
University of Adelaide, Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Wittert, MD, MB Bch, FRACP
Phone
+61 8 8222.5502
Email
gary.wittert@adelaide.edu.au
First Name & Middle Initial & Last Name & Degree
Cynthia Piantadosi, PhD

12. IPD Sharing Statement

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Weight Loss Effects on Heart and Blood Vessel Function in Obesity

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