Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545727
• Other study ID #: 06-CH-N182
• Status: Completed
• Phase: N/A
• First received: October 16, 2007
• Last updated: October 16, 2007
• Start date: July 2006
• Est. completion date: August 2006

Study information

• Verified date: September 2007
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Research to date suggests that the selection of lower glycemic index foods, that is, foods provoking a slower, more sustained blood sugar response, may result in improved glycemic control in youth with diabetes. However, there is currently insufficient data to support practice recommendations. The purpose of this pilot study is to test the blood glucose response to low and high glycemic index meals in youth with diabetes using continuous blood glucose monitoring, and to determine whether the effect of glycemic index differs by regimen or diagnosis. In this pilot study up to 42 youth with type 1 diabetes or impaired glucose metabolism (elevated fasting glucose, insulin resistance, or type 2 diabetes) will participate in 5 days of continuous blood glucose monitoring during which they will receive both low and high glycemic index meals. Children will be provided with 1 full day of low glycemic index meals and 1 full day of high glycemic index meals in a supervised setting in randomized order. Each of these test days will be preceded by a standard evening meal and snack. Continuous blood glucose monitoring will also be conducted during regular food intake ad libidum away from the clinic, as well as during one day of instructed low glycemic meals at home. All food intake, insulin, and blood glucose self-monitoring will be recorded. While in the clinic, measures of satiety and acceptability of the food will also be obtained. Data analysis will include indices of blood glucose levels and variability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

• diagnosed with type 1 diabetes for a minimum of 1 year with insulin dose greater than or equal to 0.5 u/kg/day, or diagnosed with elevated fasting glucose, insulin resistance, or type 2 diabetes

• age 7 to 16

Exclusion Criteria:

• dietary restrictions that would preclude eating the study diet

• comorbid chronic illness requiring daily medical management

• comorbid major psychiatric diagnosis

• non-English speaking/writing

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Impaired Glucose Metabolism
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Behavioral:
• Diet
Whole-foods, low glycemic index diet

Other:
• Standard diet
Standard diet meeting American Diabetes Association guidelines

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose level