Insulin Resistance in Type I Diabetes in Pediatric Care

NCT00946426 | Withdrawn

• 1 other identifier: IRB09-00160
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Baseline

Secondary Outcomes (1)

• Hepatic glucose output

  Baseline

Study Arms (1)

Diagnostic

Hyperinsulinemic euglycemic clamp

Other: Clamp

Interventions

Clamp OTHER

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

Diagnostic

Eligibility Criteria

• Age: 9 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Endocrinology clinic patients

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Constriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Dana S Hardin, MD

  The Research Institute at Nationwide Children's Hospital, The Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 27, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 15, 2015

Record last verified: 2015-05

Locations

US (1)