Comparative study between two feeding schemes for glycaemic control in children with type 1 diabetes mellitus
| ISRCTN | ISRCTN39293069 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39293069 |
| Secondary identifying numbers | 72/2008 |
- Submission date
- 25/06/2009
- Registration date
- 04/01/2010
- Last edited
- 04/01/2010
- 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 Alejandro Gonzalez
Scientific
Scientific
Av. Coyoacan 1868 - 202
Col. Acacias
Mexico City
03240
Mexico
| Phone | +52 (0)155 5524 1792 |
|---|---|
| pegasso.100@hotmail.com |
Study information
| Study design | Crossover randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparative study of the effectiveness of two schemes dietetic glycaemic index of foods with high versus low postprandial glycaemic control in children with type 1 diabetes mellitus: a controlled cross-over clinical trial |
| Study acronym | LGI, HGI |
| Study objectives | A dietetic scheme with a low glycaemic index (less than 55) will be more effective in maintaining the concentration of postprandial serum glucose (less than 180 mg/dl) than a dietetic scheme with a high glycaemic index in paediatric patients with diabetes mellitus type 1 (DM 1). |
| Ethics approval(s) | Ethics Committee of the National Institute of Pediatrics approved on the 2nd October 2008 (ref: 72/2008) |
| Health condition(s) or problem(s) studied | Type 1 diabetes mellitus |
| Intervention | Group 1 (n = 25): paediatric patients with diabetes mellitus 1 are fed with a dietetic scheme with a low glycaemic index low (less than 55) Group 2 (n = 25): paediatric patients with diabetes mellitus 1 are fed with a dietetic scheme with a high glycaemic index (greater than 55) Total duration of intervention: minimum 2 hours |
| Intervention type | Other |
| Primary outcome measure | 1. Concentration of post-prandial serum glucose 2. Type of dietetic scheme administered Measured at 15, 30, 45, 60, 90 and 120 minutes. |
| Secondary outcome measures | Security settings: 1. Abdominal pain 2. Vomiting 3. Stool consistency 4. Temperature 5. Blood in stools 6. Fasting serum glucose 7. Ketones in urine Measured at 15, 30, 45, 60, 90 and 120 minutes. |
| Overall study start date | 01/06/2009 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. DM1 patients between 10 to 18 years of age monitored by the Department of Endocrinology, National Institute of Paediatrics 2. Patients of either sex 3. Patients with controlled DM1: 3.1. Concentration of fasting serum glucose 95 - 130 mg/dl 3.2. Glycosylated haemoglobin less than 7.5% 5. Signing of informed consent and settlement 6. Eight hours of fasting 7. Treated with intermediate and/or rapid long-acting insulin for more than 6 months |
| Key exclusion criteria | 1. Patients with infectious processes at least 72 hours of admission to the protocol 2. Patients with steroid treatment less than 24 hours prior to entry into the protocol 3. Patients who performed aerobic exercise greater than 30 minutes on the day prior to the start of this protocol 4. Elevated axillary temperature greater than 38ºC at the start of the protocol (fever) |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Av. Coyoacan 1868 - 202
Mexico City
03240
Mexico
03240
Mexico
Sponsor information
National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
Government
Government
Insurgentes Sur 3700 - C
Col. Insurgentes Cuicuilco
Mexico City
03540
Mexico
| Phone | +52 (0)155 1084 0900 |
|---|---|
| pegasso.100@hotmail.com | |
| Website | http://www.salud.gob.mx/unidades/pediatria/ |
"ROR" |
https://ror.org/05adj5455 |
Funders
Funder type
Government
National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
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 |
