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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/NCT00383253
Registration number
NCT00383253
Ethics application status
Date submitted
29/09/2006
Date registered
3/10/2006
Date last updated
23/03/2009
Titles & IDs
Public title
Methods Study to Characterize Early Indicators of Weight Loss in People
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Scientific title
A Randomized, Open-Label, Parallel Group, Fixed Energy Deficit Methodology Trial to Characterize Early Efficacy Biomarkers During Treatment of Obesity in Adult, Obese, Male Subjects.
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Secondary ID [1]
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A9001342
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - caloric restriction - 10%
Behaviour - caloric restriction - 25%
Behaviour - caloric restriction - 50%
Behaviour - caloric restriction - Control
Experimental: 10% -
Experimental: 25% -
Experimental: 50% -
Placebo Comparator: Control -
Behaviour: caloric restriction - 10%
Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)
Behaviour: caloric restriction - 25%
Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)
Behaviour: caloric restriction - 50%
Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)
Behaviour: caloric restriction - Control
Subjects maintained on their baseline caloric intake (caloric restriction = none)
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers
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Assessment method [1]
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Timepoint [1]
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Throughout trial
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Secondary outcome [1]
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To evaluate the time course, magnitude and biomarkers of metabolic compensation as well as assessment of well being (via questionnaires) following varying degrees of controlled, 1-month, caloric restriction
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Assessment method [1]
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Timepoint [1]
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Throughout trial
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Eligibility
Key inclusion criteria
- Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Females, those with illnesses expected to cause weight loss, those without stable body
weight within 3 months of screening.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
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Accrual to date
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Final
57
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Pfizer Investigational Site - Adelaide
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Recruitment hospital [2]
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Pfizer Investigational Site - North Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5006 - North Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Adelaide
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Royal Adelaide Hospital
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Methods study to characterize early indicators of weight loss in people.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00383253
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00383253
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