Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/03/2011
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

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 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

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

Not Specified

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

Not provided at time of registration

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

10/09/2003

Overall trial end date

09/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 12 diabetics and 12 healthy volunteers
2. Ages 30-65

Participant type

Healthy volunteer

Age group

Adult

Gender

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

United Kingdom

Trial 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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/17299480

Publication citations

  1. Results

    Milton JE, Sananthanan CS, Patterson M, Ghatei MA, Bloom SR, Frost GS, Glucagon-like peptide-1 (7-36) amide response to low versus high glycaemic index preloads in overweight subjects with and without type II diabetes mellitus., Eur J Clin Nutr, 2007, 61, 12, 1364-1372, doi: 10.1038/sj.ejcn.1602654.

Additional files

Editorial Notes