Contact information
Type
Scientific
Primary contact
Dr Alejandro Gonzalez
ORCID ID
Contact details
Av. Coyoacan 1868 - 202
Col. Acacias
Mexico City
03240
Mexico
+52 (0)155 5524 1792
pegasso.100@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
72/2008
Study information
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/06/2009
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant 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)
Recruitment start date
01/06/2009
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Mexico
Trial participating centre
Av. Coyoacan 1868 - 202
Mexico City
03240
Mexico
Sponsor information
Organisation
National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
Sponsor details
Insurgentes Sur 3700 - C
Col. Insurgentes Cuicuilco
Mexico City
03540
Mexico
+52 (0)155 1084 0900
pegasso.100@hotmail.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary