| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN31719529 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0016132016 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Diabetes |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients with type II diabetes who attend the diabetes clinic chx |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/11/2003 |
| Anticipated end date | 01/05/2004 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Hammersmith Hospital NHS Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Gary Frost |
| Contact details | Nutrition & Dietetics Department
2nd Floor, C Block
Hammersmith Hospital
Du Cane Road
London
United Kingdom
W12 0HS |
| Contact telephone | +44 (0)208 383 3048 (bleep 9027) |
| Contact fax | +44 (0)208 383 3379 |
| Contact email | g.frost@imperial.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN31719529 |
| Date last extracted from ISRCTN register | 17/04/2008 |
