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

NCT00545727 | Completed

• 1 other identifier: 06-CH-N182
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Blood glucose level

Study Arms (2)

HGI

OTHER

High/standard glycemic index diet

Other: Standard diet

LGI

EXPERIMENTAL

Low glycemic index diet

Behavioral: Diet

Interventions

Diet BEHAVIORAL

Whole-foods, low glycemic index diet

LGI

Standard diet OTHER

Standard diet meeting American Diabetes Association guidelines

HGI

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• dietary restrictions that would preclude eating the study diet
• comorbid chronic illness requiring daily medical management
• comorbid major psychiatric diagnosis
• non-English speaking/writing

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Diet

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Tonja R. Nansel, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: July 1, 2006
• Study Completion: August 1, 2006
• Last Updated: October 17, 2007

Record last verified: 2007-09