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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
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Other: Clamp

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Insulin Resistance in Type I Diabetes in Pediatric Care

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hepatic glucose output [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diagnostic
Hyperinsulinemic euglycemic clamp
Other: Clamp
Insulin sensitivity, Hepatic glucose production, Evaluation of inflammation, Socioeconomic status, Ethnicity and family history

  Eligibility

Ages Eligible for Study:   9 Years to 23 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Endocrinology clinic patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946426

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Dana S Hardin, MD The Research Institute at Nationwide Children's Hospital, The Ohio State University
  More Information

No publications provided

Responsible Party: Dana S. Hardin, The Research Institute at Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00946426     History of Changes
Other Study ID Numbers: IRB09-00160
Study First Received: July 24, 2009
Last Updated: May 4, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Insulin Resistance
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 23, 2014