Submission date
30/09/2004
Registration date
30/09/2004
Last edited
10/03/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

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

http://www.dh.gov.uk/Home/fs/en

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

Additional files

Editorial Notes