Insulin Resistance in Type I Diabetes in Pediatric Care

Insulin Resistance in Type I Diabetes in Pediatric Care

Sponsors

Lead Sponsor: Nationwide Children's Hospital

Source 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.

Overall Status Withdrawn
Start Date July 2009
Completion Date May 2010
Primary Completion Date May 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Insulin sensitivity Baseline
Secondary Outcome
Measure Time Frame
Hepatic glucose output Baseline
Condition
Intervention

Intervention Type: Other

Intervention Name: Clamp

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

Arm Group Label: Diagnostic

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Previously diagnosed with type 1 diabetes

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

Exclusion Criteria:

- None

Gender: All

Minimum Age: 9 Years

Maximum Age: 23 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dana S Hardin, MD Principal Investigator The Research Institute at Nationwide Children's Hospital, The Ohio State University
Location
Facility: Nationwide Children's Hospital
Location Countries

United States

Verification Date

May 2015

Responsible Party

Name Title: Dana S. Hardin

Organization: The Research Institute at Nationwide Children's Hospital

Has Expanded Access No
Condition Browse
Arm Group

Label: Diagnostic

Description: Hyperinsulinemic euglycemic clamp

Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov