Insulin Resistance in Type I Diabetes in Pediatric Care

NCT ID: NCT00946426

Last Updated: 2015-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnostic

Hyperinsulinemic euglycemic clamp

Clamp

Intervention Type OTHER

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

Interventions

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Clamp

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

9 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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The Research Institute at Nationwide Children's Hospital

Principal Investigators

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Dana S Hardin, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB09-00160

Identifier Type: -

Identifier Source: org_study_id

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