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OpenTrials
Completed

NCT Number: NCT00545727

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

Whole-foods, low glycemic index diet

Standard Diet

Other

Standard diet meeting American Diabetes Association guidelines

Primary outcomes

  1. Blood glucose level

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start
2006
Study completion
2006
First posted
Oct 17, 2007
Registry last updated
Oct 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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