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

Completed

• Conditions: Type 1 diabetes mellitus; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN39293069
• Lead Sponsor: ational Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Concentration of post-prandial serum glucose <br>2. Type of dietetic scheme administered <br><br>Measured at 15, 30, 45, 60, 90 and 120 minutes.

Secondary Outcome Measures

Name	Time	Method
Security settings: <br>1. Abdominal pain<br>2. Vomiting<br>3. Stool consistency<br>4. Temperature<br>5. Blood in stools<br>6. Fasting serum glucose <br>7. Ketones in urine<br><br>Measured at 15, 30, 45, 60, 90 and 120 minutes.