MedPath

Insulin Resistance in Type I Diabetes in Pediatric Care

Withdrawn
Conditions
Type 1 Diabetes
Interventions
Other: Clamp
Registration Number
NCT00946426
Lead Sponsor
Nationwide Children's Hospital
Brief Summary

24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the presence of hepatic and peripheral insulin resistance. The investigators will use this pilot information to test the hypothesis that insulin resistance occurs in some children with type 1 DM, is secondary to underlying risk factors, and is responsible for increased insulin needs. Methods will include a "step-up" hyperinsulinemic euglycemic clamp and infusion of the stable isotope 6,6-\[2H2\]-glucose. Patient and parent interviews will be conducted to gather information about nutritional intake, ethnicity, family history, and socioeconomic status. The investigators will also measure inflammatory cytokines and free fatty acids to determine whether they are associated with differences in insulin resistance among type 1 diabetes mellitus patients.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Previously diagnosed with type 1 diabetes
  • ages 9 -11 tanner 1 or 16-23 tanner 4-5
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
DiagnosticClampHyperinsulinemic euglycemic clamp
Primary Outcome Measures
NameTimeMethod
Insulin sensitivityBaseline
Secondary Outcome Measures
NameTimeMethod
Hepatic glucose outputBaseline

Trial Locations

Locations (1)

Nationwide Children's Hospital

🇺🇸

Columbus, Ohio, United States

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