Reduce Obesity and Diabetes



Status:Completed
Conditions:High Cholesterol, Obesity Weight Loss, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:10 - 15
Updated:4/2/2016
Start Date:July 2006
End Date:June 2012
Contact:Michael Rosenbaum, M.D.
Email:mr475@columbia.edu
Phone:212-305-9949

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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.

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.

Inclusion Criteria:

- Children in 6th-8th grade

Exclusion Criteria:

- Diabetes

- Exercise induced asthma

- Pregnancy

- Any chronic medication that interferes with glucose homeostasis
We found this trial at
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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New York, New York 10029
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