Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/06/2009
Date assigned
04/01/2010
Last edited
04/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.salud.gob.mx/unidades/pediatria/

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

Publication citations

Additional files

Editorial Notes