Subcutaneous oxyntomodulin reduces body-weight in overweight subjects
ISRCTN | ISRCTN33638415 |
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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
Scientific
Hammersmith Hospital
Commonwealth Building
Department of Metabolic Medicine
Du Cane Road
London
W12 0NN
United Kingdom
Phone | +44 (0)20 8383 3242 |
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s.bloom@imperial.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Subcutaneous oxyntomodulin reduces body-weight in overweight subjects |
Study objectives | 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. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Obesity |
Intervention | 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. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Oxyntomodulin |
Primary outcome measure | Body weight, energy intake and adipose hormones. |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 02/01/2004 |
Completion date | 31/08/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 26 |
Key inclusion criteria | 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 |
Key exclusion criteria | 1. 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 enrolment | 02/01/2004 |
Date of final enrolment | 01/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hammersmith Hospital
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
Level 2, Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
England
United Kingdom
clinical.researchoffice@imperial.ac.uk | |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |