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Reduce Obesity and Diabetes (ROAD)

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ClinicalTrials.gov Identifier: NCT00954577
Recruitment Status : Unknown
Verified August 2009 by Academy for Medical Development and Collaboration, New York.
Recruitment status was:  Recruiting
First Posted : August 7, 2009
Last Update Posted : August 7, 2009
Information provided by:
Academy for Medical Development and Collaboration, New York

Brief Summary:

This study examines risk factors for type 2 diabetes in children representing multiple discrete ethnic groups. It also examines the short term effects of school-based health education supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children. The investigators hypothesize that exercise and health education 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 effect on insulin secretory capacity 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 in all children, regardless of their level of diabetes risk.

Condition or disease Intervention/treatment
Type 2 Diabetes Pediatric Obesity Dyslipidemia Behavioral: Nutrition, health, and exercise education

Detailed Description:
The prevalence of type 2 diabetes mellitus (type 2 DM) among adolescents has increased > 10 fold over the past decade. Type 2 DM reflects the interactions of genes/traits conveying an increased risk of impaired function of the pancreatic cells that secrete insulin (islet cells)and muscle/liver insulin sensitivity with environmental factors such as reduced levels of activity and increasing adiposity. Both impaired islet cell function and insulin resistance are independently associated with increased risk of subsequent diabetes mellitus and may be considered as 'prediabetic' phenotypes. This study examines the prevalence of prediabetic phenotypes and the effects of supervised exercise/nutrition education on risk factors for type 2 DM in 6th-8th grade students who will undergo a 5 minute intravenous glucose tolerance test, as well as measurements of other diabetes risk factors including family history, body composition, circulating concentrations of molecules (cytokines) that are markers of inflammation , and lipid profiles, before and after participating in the intervention. These studies will also be used to calculate both the ability of the pancreas to secrete insulin and the sensitivity of the students to insulin. No previous studies have isolated the effects of exercise and nutrition education on different diabetes subphenotypes in children. To insure the necessary ethnic diversity necessary to these studies, data will be pooled in a multisite study with Mt. Sinai, North Shore/LIJ, Maimonides, and Winthrop Hospitals. We will remain in contact with students to track subsequent development of diabetes intervention effects on lifestyle. We hypothesize that diabetes risk in most students will be reduced by exercise and education in a healthy lifestyle but that the type of health benefit (i.e., improved body fatness, improved insulin sensitivity, improved insulin secretion, improved cholesterol, or decreased inflammation) will be different between ethnic groups. The results of these studies will, we believe, demonstrate the benefits of health and physical education programs to all students, regardless of diabetes risk, and will also enable us to better understand how diabetes develops in children and what expectations we can have for health improvement in different ethnic groups from such an intervention.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Pathogenesis of Type 2 Diabetes in Children and Utility of a School-based Intervention to Reduce Obesity and Diabetes in Children
Study Start Date : July 2006
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: Nutrition, health, and exercise education
    The classroom intervention is part of the routine science curriculum and consists of 14 sessions taught by the investigators. Topics covered include the development of type 2 diabetes, nutrition education, exercise education, and overall healthy lifestyle education (both at home and in school). The intervention is offered in each year to all grades and to all students, regardless of whether or not they are enrolled in the study. The exercise intervention is optional and consists of 2-3 sessions per week of aerobic exercise (dancing) taught by pediatric trainers and offered in lieu of regular gym classes.

Primary Outcome Measures :
  1. Reduction in diabetes risk factors including insulin secretory capacity, insulin sensitivity, body fat content, dyslipidemia, and circulating concentrations of pro-inflammatory cytokines. [ Time Frame: In December and May of each school year ]

Secondary Outcome Measures :
  1. Improvement in self-esteem and in health-related behaviors. [ Time Frame: December and May of each school year ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children in 6th-8th grade.

Inclusion Criteria:

  • Children in 6th-8th grade

Exclusion Criteria:

  • Diabetes
  • Exercise induced asthma
  • Pregnancy
  • Any chronic medication that interferes with glucose homeostasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954577

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Contact: Michael Rosenbaum, M.D. 212-305-9949 mr475@columbia.edu
Contact: Steven Shelov, M.D. 718-283-6150 sshelov@maimonidesmed.org

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United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Deborah DeSantis, Ph.D.    718-283-6814    ddesantis@maimonidesmed.org   
Principal Investigator: Deborah DeSantis, Ph.D.         
North Shore LIJ Schneider Children's Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Phyllis Speiser, M.D.    718-470-3290    pspeiser@LIJ.edu   
Principal Investigator: Phyllis Speiser, M.D.         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Warren Rosenfeld, M.D.    516-663-2288    wrosenfeld@winthrop.org   
Principal Investigator: Warren Rosenfeld, M.D.         
Mt. Sinai Medical Center Recruiting
New York, New York, United States, 10028
Contact: Robert Rapaport, MD    212-241-8487    robert.rapaport@msnyuhealth.org   
Principal Investigator: Robert Rapaport, M.D.         
Columbia University Medical Center/The New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Ilene Fennoy, M.D.. M.P.H.    212-851-5315    if1@columbia.edu   
Principal Investigator: Ilene Fennoy, M.D., M.P.H.         
Sponsors and Collaborators
Academy for Medical Development and Collaboration, New York
Publications of Results:
Other Publications:
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Responsible Party: Maria Mitchell, Ph.D., President, AMDeC
ClinicalTrials.gov Identifier: NCT00954577    
Other Study ID Numbers: amdecroad
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009
Keywords provided by Academy for Medical Development and Collaboration, New York:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Pediatric Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Lipid Metabolism Disorders