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ISRCTN
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ISRCTN33638415
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ClinicalTrials.gov identifier
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Public title
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Subcutaneous oxyntomodulin reduces body-weight in overweight subjects
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Scientific title
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Acronym
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N/A
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Serial number at source
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071446
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Study hypothesis
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The effect of self-administered subcutaneous oxyntomodulin on overweight volunteers was investigated in a four week community-based study. We hypothesised oxyntomodulin would reduce body weight and appetite.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Obesity
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Participants - inclusion criteria
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1. Healthy male and female volunteers, aged 18 to 55 years
2. A stable Body Mass Index (BMI) between 25 and 40 kg/m^2
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Participants - exclusion criteria
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1. Abnormal eating behaviour
2. A current medical condition
3. Abnormal ElectroCardioGram (ECG)
4. Abnormal blood tests
5. Pregnancy or breast-feeding
6. Blood donation or participation in another research study within the last three months
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Anticipated start date
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02/01/2004
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Anticipated end date
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31/08/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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26 - recruitment ends on the 1st July 2004
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Interventions
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Healthy overweight volunteers self-administered either saline or oxyntomodulin subcutaneously for four weeks, three times daily, 30 minutes before each meal, in a randomised double-blind parallel-group protocol. The volunteers were asked to maintain their regular diet and level of physical exercise. Subjects' body weight, energy intake and levels of adipose hormones were assessed at the start and end of the study.
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Primary outcome measure(s)
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Body weight, energy intake and adipose hormones.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 071446)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/16046306
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Contact name
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Prof
S R
Bloom
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Address
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Hammersmith Hospital
Commonwealth Building
Department of Metabolic Medicine
Du Cane Road
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City/town
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London
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Zip/Postcode
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W12 0NN
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Country
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United Kingdom
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Tel
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+44 (0)20 8383 3242
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Fax
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+44 (0)20 8383 3142
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Email
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s.bloom@imperial.ac.uk
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Sponsor
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Imperial College London (UK)
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Address
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Level 2, Faculty Building
Clinical Research Office
South Kensington campus
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Email
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clinical.researchoffice@imperial.ac.uk
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Date applied
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22/07/2005
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Last edited
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04/08/2008
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Date ISRCTN assigned
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22/07/2005
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