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 |
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| 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. |
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| Overall Status | Withdrawn | ||||||
| Start Date | July 2009 | ||||||
| Completion Date | May 2010 | ||||||
| Primary Completion Date | May 2010 | ||||||
| Study Type | Observational | ||||||
| Primary Outcome |
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| Secondary Outcome |
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| 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 |
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| 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 |
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| Overall Official |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
May 2015 |
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| Responsible Party |
Name Title: Dana S. Hardin Organization: The Research Institute at Nationwide Children's Hospital |
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| Has Expanded Access | No | ||||||
| Condition Browse | |||||||
| Arm Group |
Label: Diagnostic Description: Hyperinsulinemic euglycemic clamp |
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| Study Design Info |
Observational Model: Case-Only Time Perspective: Prospective |
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