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Home > "P" Clinical Trials Conditions > Prevention of Type 2 Diabetes Mellitus in Children  Prevention of Type 2 Diabetes Mellitus in Children
Prevention of Type 2 Diabetes Mellitus in Children
For Condition: Diabetes Mellitus, Type 2
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: This is a pilot study to examine the short-term effects of supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children from a population that is at high risk for this disease. We hypothesize that exercise will significantly improve insulin sensitivity in all children, especially in children who are already insulin resistant, thereby lowering the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses being tested are: 1. Insulin resistance will be most evident in overweight children while an impaired ability of the pancreas to release insulin will be most evident in children with a family history of type 2 diabetes mellitus. 2. Exercise will significantly improve insulin resistance (as measured by the fasting glucose/insulin ratio) with little or no effect on insulin secretory capacity (as measured by circulating insulin concentration at 1, 3, and 5 minutes following an intravenous glucose load) in children. 3. Participation in a school-based health, nutrition, and exercise education program will have long-term beneficial effects on health-related behaviors and on insulin resistance.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 12 Years/15 Years
Genders: Both
Protocol Entry Criteria: Early adolescent
Total Enrollment: 300
Location and Contact Information:
Russ Berrie Pavilion *Recruiting*
New York City, New York, 10032
United States
Recruiting Michael Rosenbaum
New York Presbyterian Hospital *Recruiting*
New York City, New York,
United States
Recruiting Michael Rosenbaum 212-769-3070
Additional Information:
Study ID Numbers: 14239;
Study Start Date: December 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073268
Other Diabetes Mellitus, Type 2 Studies:
1. Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin
2. Evaluation of the Effect of Pramlintide on Satiety and Food Intake
3. Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
4. Computer-assisted diabetes self-management interventions
5. Evaluation of the Bioavailability of Pramlintide
Related Studies:
Other Diabetes Mellitus, Type 2 Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Prevention of Type 2 Diabetes Mellitus in Children
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