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

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00545727
First received: October 16, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

October 16, 2007
October 16, 2007
July 2006
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Blood glucose level
Same as current
No Changes Posted
Not Provided
Not Provided
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Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes
Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes

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.

Not Provided
Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Impaired Glucose Metabolism
  • Behavioral: Diet
    Whole-foods, low glycemic index diet
  • Other: Standard diet
    Standard diet meeting American Diabetes Association guidelines
  • HGI
    High/standard glycemic index diet
    Intervention: Other: Standard diet
  • Experimental: LGI
    Low glycemic index diet
    Intervention: Behavioral: Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2006
Not Provided

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
Both
7 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00545727
06-CH-N182
No
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Tonja R. Nansel, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP