Reduce Obesity and Diabetes (ROAD)

August 6, 2009 updated by: Academy for Medical Development and Collaboration, New York

The Pathogenesis of Type 2 Diabetes in Children and Utility of a School-based Intervention to Reduce Obesity and Diabetes in Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Medical Center
        • Contact:
        • Principal Investigator:
          • Deborah DeSantis, Ph.D.
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore LIJ Schneider Children's Hospital
        • Contact:
        • Principal Investigator:
          • Phyllis Speiser, M.D.
      • Mineola, New York, United States, 11501
        • Recruiting
        • Winthrop University Hospital
        • Contact:
        • Principal Investigator:
          • Warren Rosenfeld, M.D.
      • New York, New York, United States, 10028
        • Recruiting
        • Mt. Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Robert Rapaport, M.D.
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/The New York Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Ilene Fennoy, M.D., M.P.H.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children in 6th-8th grade.

Description

Inclusion Criteria:

  • Children in 6th-8th grade

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
In December and May of each school year

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in self-esteem and in health-related behaviors.
Time Frame: December and May of each school year
December and May of each school year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academy for Medical Development and Collaboration, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Estimate)

August 7, 2009

Last Update Submitted That Met QC Criteria

August 6, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • amdecroad

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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