Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Insulin Resistance in Type I Diabetes in Pediatric Care

This study has been terminated.
(PI left institution)
Sponsor:
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00946426
First received: July 24, 2009
Last updated: May 4, 2010
Last verified: July 2009

July 24, 2009
May 4, 2010
July 2009
December 2009   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00946426 on ClinicalTrials.gov Archive Site
Hepatic glucose output [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Insulin Resistance in Type I Diabetes in Pediatric Care
Insulin Resistance in Type I Diabetes in Pediatric Care

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Endocrinology clinic patients

Type 1 Diabetes
Other: Clamp
Insulin sensitivity, Hepatic glucose production, Evaluation of inflammation, Socioeconomic status, Ethnicity and family history
Diagnostic
Hyperinsulinemic euglycemic clamp
Intervention: Other: Clamp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
June 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previously diagnosed with type 1 diabetes
  • ages 9 -11 tanner 1 or 16-23 tanner 4-5

Exclusion Criteria:

  • None
Both
9 Years to 23 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00946426
IRB09-00160
No
Dana S. Hardin, The Research Institute at Nationwide Children's Hospital
Nationwide Children's Hospital
Not Provided
Principal Investigator: Dana S Hardin, MD The Research Institute at Nationwide Children's Hospital, The Ohio State University
Nationwide Children's Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP