Insulin Resistance and Insulin Secretion

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00073294
First received: November 18, 2003
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Phenotypic Assessment of Insulin Resistance and Insulin Secretory Capacity

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 200
  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073294

Locations
United States, New York
Columbia Presbyterian Medical Center/ Irving Center
New York, New York, United States, 10032
Russ Berrie Pavilion
New York, New York, United States, 10032
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00073294     History of Changes
Other Study ID Numbers: 9777 (completed)
Study First Received: November 18, 2003
Last Updated: January 14, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013