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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00545727
First Posted: October 17, 2007
Last Update Posted: October 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Purpose
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
Type 1 Diabetes Type 2 Diabetes Impaired Glucose Metabolism Behavioral: Diet Other: Standard diet

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Blood glucose level

Enrollment: 36
Study Start Date: July 2006
Study Completion Date: August 2006
Arms Assigned Interventions
HGI
High/standard glycemic index diet
Other: Standard diet
Standard diet meeting American Diabetes Association guidelines
Experimental: LGI
Low glycemic index diet
Behavioral: Diet
Whole-foods, low glycemic index diet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545727


Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Tonja R. Nansel, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

ClinicalTrials.gov Identifier: NCT00545727     History of Changes
Other Study ID Numbers: 06-CH-N182
First Submitted: October 16, 2007
First Posted: October 17, 2007
Last Update Posted: October 17, 2007
Last Verified: September 2007

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Diabetes
Children
Adolescents
Diet
Glycemic index

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases