Contact information
Type
Scientific
Primary contact
Prof S R Bloom
ORCID ID
Contact details
Hammersmith Hospital
Commonwealth Building
Department of Metabolic Medicine
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)20 8383 3242
s.bloom@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
071446
Study information
Scientific title
Subcutaneous oxyntomodulin reduces body-weight in overweight subjects
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Oxyntomodulin
Primary outcome measures
Body weight, energy intake and adipose hormones.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
02/01/2004
Overall trial end date
31/08/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
26
Participant 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
Recruitment start date
02/01/2004
Recruitment end date
01/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hammersmith Hospital
London
W12 0NN
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Level 2
Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
United Kingdom
-
clinical.researchoffice@imperial.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16046306
Publication citations
-
Results
Wynne K, Park AJ, Small CJ, Patterson M, Ellis SM, Murphy KG, Wren AM, Frost GS, Meeran K, Ghatei MA, Bloom SR, Subcutaneous oxyntomodulin reduces body weight in overweight and obese subjects: a double-blind, randomized, controlled trial., Diabetes, 2005, 54, 8, 2390-2395.