Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/03/2016
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

Dr Gary Frost

ORCID ID

Contact details

Nutrition & Dietetics Department
2nd Floor
C Block
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)208 383 3048 (bleep 9027)
g.frost@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016132016

Study information

Scientific title

A pilot study to investigate the effects of increasing meal frequency and snacking on blood glucose measurements in patients with type two diabetes on insulin treatment

Acronym

Study hypothesis

What this study hopes to answer is whether giving appropriate advice on snacking and spreading out the Kcal intake throughout the day reduces the incidence of hypoglycaemia and improves control in patients with type II diabetes on insulin without increasing Kcal intake

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

Diabetes

Intervention

Inclusion of snacks and reduction of main meal portions will reduce overall measurements of blood glucose and reduce incidence of hypoglycaemic episodes whilst maintaining similar energy intake per day.
The study design is a randomized controlled trial. Subjects will be randomly assigned to intervention or control groups.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The results will be incorporated into the departments dietetic protocol and may be used alter the focus of dietary advice for this patient group to help in the prevention of hypoglycaemia and weight gain. It will also highlight areas for further research.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2003

Overall trial end date

01/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with type II diabetes who attend the diabetes clinic chx

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/11/2003

Recruitment end date

01/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nutrition & 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

Hospital/treatment centre

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

Publication citations

Additional files

Editorial Notes

01/03/2016: No publications found, verifying study status with principal investigator.