Insulin Resistance in Type I Diabetes in Pediatric Care

Type 1 Diabetes Clinical Trial

Official title:

Insulin Resistance in Type I Diabetes in Pediatric Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00946426
• Other study ID #: IRB09-00160
• Status: Withdrawn
• Phase: N/A
• First received: July 24, 2009
• Last updated: May 14, 2015
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 23 Years

Eligibility

Inclusion Criteria:

• Previously diagnosed with type 1 diabetes

• ages 9 -11 tanner 1 or 16-23 tanner 4-5

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Insulin Resistance
• Type 1 Diabetes

Intervention

Other:
• Clamp
Insulin sensitivity, Hepatic glucose production, Evaluation of inflammation, Socioeconomic status, Ethnicity and family history

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		Baseline	No
Secondary	Hepatic glucose output		Baseline	No