Insulin Resistance and Insulin Secretion - Tabular View

Tracking Information
First Received Date ^ICMJE	November 18, 2003
Last Updated Date	January 14, 2010
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00073294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Insulin Resistance and Insulin Secretion
Official Title ^ICMJE	Phenotypic Assessment of Insulin Resistance and Insulin Secretory Capacity
Brief Summary	This is a pilot study to examine the prevalence of metabolic risk factors (impaired insulin release and impaired insulin sensitivity) for type 2 diabetes mellitus in children and adults from a population that is at high risk for this disease. We hypothesize that at least one of these pre-diabetic traits will be evident in a large proportion of relatives of known type 2 diabetic children as compared to a control group of subjects without a family history of type 2 diabetes. By isolating these traits, it will be possible to determine the relative contributions of genes and environment to each trait and to identify those at risk for subsequent development of type 2 diabetes by virtue of having one trait. Ultimately, those individuals at risk, especially those with impaired insulin release, would hopefully benefit from intervention to prevent the weight gain that will 'unmask' their underlying pancreatic dysfunction and thus prevent or retard the development of type 2 diabetes.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Prevention
Condition ^ICMJE	Diabetes Mellitus, Type 2
Intervention ^ICMJE	Behavioral: diet
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	200
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Ascertainment criteria for probands: age 10-20 years and obesity (BMI >85% for sex and age) diabetic criteria as described above or family history (first or second degree relative) with type 2 diabetes
Gender	Both
Ages	10 Years to 20 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00073294
Responsible Party
Study ID Numbers ^ICMJE	9777 (completed)
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP