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| [ Print-friendly version ] |
| Comparative study between two feeding schemes for glycaemic control in children with type 1 diabetes mellitus |
| ISRCTN | ISRCTN39293069 |
| ClinicalTrials.gov identifier | |
| Public title | Comparative study between two feeding schemes for glycaemic control in children with type 1 diabetes mellitus |
| 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 |
| Acronym | LGI, HGI |
| Serial number at source | 72/2008 |
| Study hypothesis | 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 | Ethics Committee of the National Institute of Pediatrics approved on the 2nd October 2008 (ref: 72/2008) |
| Study design | Crossover randomised controlled trial |
| Countries of recruitment | Mexico |
| Disease/condition/study domain | Type 1 diabetes mellitus |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/06/2009 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 50 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding | National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico) |
| Trial website | |
| Publications | |
| Contact name | Dr Alejandro Gonzalez |
| Address |
Av. Coyoacan 1868 - 202
Col. Acacias |
| City/town | Mexico City |
| Zip/Postcode | 03240 |
| Country | Mexico |
| Tel | +52 (0)155 5524 1792 |
| pegasso.100@hotmail.com | |
| Sponsor | National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico) |
| Address |
Insurgentes Sur 3700 - C
Col. Insurgentes Cuicuilco |
| City/town | Mexico City |
| Zip/Postcode | 03540 |
| Country | Mexico |
| Tel | +52 (0)155 1084 0900 |
| pegasso.100@hotmail.com | |
| Sponsor website: | http://www.salud.gob.mx/unidades/pediatria/ |
| Date applied | 25/06/2009 |
| Last edited | 04/01/2010 |
| Date ISRCTN assigned | 04/01/2010 |
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| © 2010 ISRCTN unless otherwise stated. | |
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