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Insulin Resistance in Type I Diabetes in Pediatric Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946426
Recruitment Status : Withdrawn (PI left institution)
First Posted : July 27, 2009
Last Update Posted : May 15, 2015
Information provided by:
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Other: Clamp

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Insulin Resistance in Type I Diabetes in Pediatric Care
Study Start Date : July 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
Hyperinsulinemic euglycemic clamp
Other: Clamp
Insulin sensitivity, Hepatic glucose production, Evaluation of inflammation, Socioeconomic status, Ethnicity and family history

Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Hepatic glucose output [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Endocrinology clinic patients

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946426

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
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Principal Investigator: Dana S Hardin, MD The Research Institute at Nationwide Children's Hospital, The Ohio State University
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Responsible Party: Dana S. Hardin, The Research Institute at Nationwide Children's Hospital Identifier: NCT00946426    
Other Study ID Numbers: IRB09-00160
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases