Contact information
Type
Scientific
Contact name
Miss Joanne Milton
ORCID ID
Contact details
Nutrition and Dietetics Department
Imperial College
Hammersmith Campus
London
W12 0HS
United Kingdom
+44 (0)208 383 5802
JMilton@hhnt.org
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0016132030
Study information
Scientific title
Acronym
Study hypothesis
1. To investigate the effects of drinks of differing glycaemic index (GI) on plasma GLP-1 concentrations and subsequent metabolic responses to a meal.
2. To determine if a low GI drink will cause a greater increase in postprandial GLP-1 concentrations and result in improved metabolic response compared to a high GI drink or water at a subsequent meal.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Diabetes
Intervention
Not provided at time of registration
Intervention type
Other
Primary outcome measure
Diet is the first line treatment for Type 2 diabetes, however the optimal diet to promote good glycaemic control is still debated. GLP-1 is being investigated as an agent for the treatment of diabetes, however it has its shortcomings due to its short half life in humans. A specific food that could be consumed before a meal to stimulate release of GLP-1 and thus improve glycaemic control would be highly beneficial to patients, and potentially have fewer side effects and be less invasive than subcutaneous administration of the hormone.
Secondary outcome measures
Not provided at time of registration
Overall study start date
10/09/2003
Overall study end date
09/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 12 diabetics and 12 healthy volunteers
2. Ages 30-65
Participant type(s)
Healthy volunteer
Age group
Adult
Sex
Not Specified
Target number of participants
24
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
10/09/2003
Recruitment end date
09/09/2007
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Nutrition and Dietetics Department
London
W12 0HS
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Hammersmith Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/12/2007 | Yes | No |