Subcutaneous oxyntomodulin reduces body-weight in overweight subjects

ISRCTN ISRCTN33638415
DOI https://doi.org/10.1186/ISRCTN33638415
Secondary identifying numbers 071446
Submission date
22/07/2005
Registration date
22/07/2005
Last edited
06/02/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof S R Bloom
Scientific

Hammersmith Hospital
Commonwealth Building
Department of Metabolic Medicine
Du Cane Road
London
W12 0NN
United Kingdom

Phone +44 (0)20 8383 3242
Email s.bloom@imperial.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleSubcutaneous oxyntomodulin reduces body-weight in overweight subjects
Study objectivesThe 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.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedObesity
InterventionHealthy 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Oxyntomodulin
Primary outcome measureBody weight, energy intake and adipose hormones.
Secondary outcome measuresNo secondary outcome measures
Overall study start date02/01/2004
Completion date31/08/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants26
Key inclusion criteria1. Healthy male and female volunteers, aged 18 to 55 years
2. A stable Body Mass Index (BMI) between 25 and 40 kg/m^2
Key exclusion criteria1. Abnormal eating behaviour
2. A current medical condition
3. Abnormal ElectroCardioGram (ECG)
4. Abnormal blood tests
5. Pregnancy or breastfeeding
6. Blood donation or participation in another research study within the last three months
Date of first enrolment02/01/2004
Date of final enrolment01/07/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Hammersmith Hospital
London
W12 0NN
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

Level 2, Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
England
United Kingdom

Email clinical.researchoffice@imperial.ac.uk
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2005 Yes No