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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00073294
Other study ID # 9777 (completed)
Secondary ID
Status Withdrawn
Phase N/A
First received November 18, 2003
Last updated February 28, 2018

Study information

Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 10 Years to 20 Years
Eligibility 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

Study Design


Intervention

Behavioral:
diet


Locations

Country Name City State
United States Columbia Presbyterian Medical Center/ Irving Center New York New York
United States Russ Berrie Pavilion New York New York

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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