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 |
| Protocol serial number | N0016132016 |
| Sponsor | Department of Health |
| Funder | Hammersmith Hospital NHS Trust (UK) |
- 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
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) |
|---|---|
| g.frost@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Nutrition & Dietetics Department
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
