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Insulin Resistance and Insulin Secretion

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Withdrawn

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: diet

Study type

Interventional

Funder types

NIH

Identifiers

NCT00073294
9777 (completed)

Details and patient eligibility

About

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.

Sex

All

Ages

10 to 20 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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