Reduce Obesity and Diabetes

Type 2 Diabetes Clinical Trial

— ROAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00954577
• Other study ID #: amdecroad
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2009
• Last updated: August 6, 2009
• Start date: July 2006
• Est. completion date: June 2012

Study information

• Verified date: August 2009
• Source: Academy for Medical Development and Collaboration, New York
• Contact: Michael Rosenbaum, M.D.
• Phone: 212-305-9949
• Email: mr475[@]columbia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children in 6th-8th grade

Exclusion Criteria:

• Diabetes

• Exercise induced asthma

• Pregnancy

• Any chronic medication that interferes with glucose homeostasis

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Obesity
• Pediatric Obesity
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York
United States	North Shore LIJ Schneider Children's Hospital	Manhasset	New York
United States	Winthrop University Hospital	Mineola	New York
United States	Columbia University Medical Center/The New York Presbyterian Hospital	New York	New York
United States	Mt. Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Academy for Medical Development and Collaboration, New York

Country where clinical trial is conducted

United States, 

References & Publications (2)

Rosenbaum M, Nonas C, Horlick M, Fennoy I, Vargas I, Schachner H, Kringas P, Stanton K, Weil R; Camino Diabetes Prevention Group. beta-Cell function and insulin sensitivity in early adolescence: association with body fatness and family history of type 2 diabetes mellitus. J Clin Endocrinol Metab. 2004 Nov;89(11):5469-76. — View Citation

Rosenbaum M, Nonas C, Weil R, Horlick M, Fennoy I, Vargas I, Kringas P; Camino Diabetes Prevention Group. School-based intervention acutely improves insulin sensitivity and decreases inflammatory markers and body fatness in junior high school students. J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in diabetes risk factors including insulin secretory capacity, insulin sensitivity, body fat content, dyslipidemia, and circulating concentrations of pro-inflammatory cytokines.		In December and May of each school year	No
Secondary	Improvement in self-esteem and in health-related behaviors.		December and May of each school year	No