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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00782262




Registration number
NCT00782262
Ethics application status
Date submitted
28/10/2008
Date registered
31/10/2008
Date last updated
31/10/2008

Titles & IDs
Public title
Weight Loss Effects on Heart and Blood Vessel Function in Obesity
Scientific title
Effects of Obesity and Diet Induced Weight Loss on Cardiovascular Risk Factors, Vascular and Ventricular Structure and Function in Obese Men
Secondary ID [1] 0 0
050226
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - KicStart™

Other: Group 1 (n=20) - BP < 140/90, no diabetes mellitus and fasting glucose < 5.5

Other: Group 2 (n=20) - BP > 140/100, no diabetes mellitus and fasting glucose < 5.5

Other: Group 3 (n=20) - BP <140/100, no diabetes mellitus, fasting glucose 5.5 - 6.9


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
4 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Adelaide Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00782262
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cynthia Piantadosi, PhD
Address 0 0
Country 0 0
Phone 0 0
61 8 82222473
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00782262