Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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)

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

  1. 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.

Additional files

Editorial Notes