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Comparative study between two feeding schemes for glycaemic control in children with type 1 diabetes mellitus

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39293069
Enrollment
50
Registered
2010-01-04
Start date
2009-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

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

Sponsors

National Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
1. Concentration of post-prandial serum glucose 2. Type of dietetic scheme administered Measured at 15, 30, 45, 60, 90 and 120 minutes.

Secondary

MeasureTime frame
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.

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026