- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00946426
Insulin Resistance in Type I Diabetes in Pediatric Care
May 14, 2015 updated by: Nationwide Children's Hospital
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.
Study Overview
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Endocrinology clinic patients
Description
Inclusion Criteria:
- Previously diagnosed with type 1 diabetes
- ages 9 -11 tanner 1 or 16-23 tanner 4-5
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diagnostic
Hyperinsulinemic euglycemic clamp
|
Insulin sensitivity, Hepatic glucose production, Evaluation of inflammation, Socioeconomic status, Ethnicity and family history
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin sensitivity
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hepatic glucose output
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dana S Hardin, MD, The Research Institute at Nationwide Children's Hospital, The Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
July 24, 2009
First Submitted That Met QC Criteria
July 24, 2009
First Posted (Estimate)
July 27, 2009
Study Record Updates
Last Update Posted (Estimate)
May 15, 2015
Last Update Submitted That Met QC Criteria
May 14, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB09-00160
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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