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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00545727 |
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.
Condition | Intervention |
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Type 1 Diabetes Type 2 Diabetes Impaired Glucose Metabolism |
Behavioral: Diet Other: Standard diet |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Crossover Assignment, Efficacy Study |
Official Title: | Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes |
Enrollment: | 36 |
Study Start Date: | July 2006 |
Study Completion Date: | August 2006 |
Arms | Assigned Interventions |
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HGI
High/standard glycemic index diet
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Other: Standard diet
Standard diet meeting American Diabetes Association guidelines
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LGI: Experimental
Low glycemic index diet
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Behavioral: Diet
Whole-foods, low glycemic index diet
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Ages Eligible for Study: | 7 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 06-CH-N182 |
Study First Received: | October 16, 2007 |
Last Updated: | October 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00545727 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Diabetes Children Adolescents Diet Glycemic index |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |