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Insulin Resistance in Type I Diabetes in Pediatric Care

Insulin Resistance in Type I Diabetes in Pediatric Care

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00946426
Enrollment
0
Registered
2009-07-27
Start date
2009-07-31
Completion date
2010-05-31
Last updated
2015-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Interventions

OTHERClamp

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

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to 23 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Insulin sensitivityBaseline

Secondary

MeasureTime frame
Hepatic glucose outputBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026