A pilot study to investigate the effects of increasing meal frequency and snacking on blood glucose measurements in patients with type 2 diabetes on insulin treatment

ISRCTN	ISRCTN31719529
DOI	https://doi.org/10.1186/ISRCTN31719529
Secondary identifying numbers	N0016132016

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 25/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gary Frost
Scientific

Nutrition & Dietetics Department
2nd Floor, C Block
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Phone	+44 (0)208 383 3048 (bleep 9027)
Email	g.frost@imperial.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	A pilot study to investigate the effects of increasing meal frequency and snacking on blood glucose measurements in patients with type 2 diabetes on insulin treatment
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2003
Completion date	01/05/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients with type II diabetes who attend the diabetes clinic chx
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/11/2003
Date of final enrolment	01/05/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Nutrition & Dietetics Department

London
W12 0HS
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

Hammersmith Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

24/05/2018: No publications found, verifying study status with principal investigator.
01/03/2016: No publications found, verifying study status with principal investigator.