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

NCT ID: NCT00545727

Last Updated: 2007-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2006-08-31

Brief 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.

Conditions

Type 1 Diabetes; Type 2 Diabetes; Impaired Glucose Metabolism

Keywords

Diabetes; Children; Adolescents; Diet; Glycemic index

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HGI

High/standard glycemic index diet

Group Type: OTHER

Standard diet

Intervention Type: OTHER

Standard diet meeting American Diabetes Association guidelines

LGI

Low glycemic index diet

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Whole-foods, low glycemic index diet

Interventions

Diet

Whole-foods, low glycemic index diet

Intervention Type: BEHAVIORAL

Standard diet

Standard diet meeting American Diabetes Association guidelines

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Principal Investigators

Tonja R. Nansel, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

06-CH-N182

Identifier Type: -

Identifier Source: org_study_id