Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition, health, and exercise education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in self-esteem and in health-related behaviors. | December and May of each school year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Children in 6th-8th grade.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Rosenbaum, M.D. | Contact | 212-305-9949 | mr475@columbia.edu | |
| Steven Shelov, M.D. | Contact | 718-283-6150 | sshelov@maimonidesmed.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Recruiting | Brooklyn | New York | 11219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15531499 | Background | 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. doi: 10.1210/jc.2004-0971. | |
| 17090635 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D063766 | Pediatric Obesity |
| D050171 | Dyslipidemias |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D006262 | Health |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
Not provided
Not provided
Not provided
Not provided
Not provided
serum
| North Shore LIJ Schneider Children's Hospital | Recruiting | Manhasset | New York | 11030 | United States |
|
| Winthrop University Hospital | Recruiting | Mineola | New York | 11501 | United States |
|
| Mt. Sinai Medical Center | Recruiting | New York | New York | 10028 | United States |
|
| Columbia University Medical Center/The New York Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
|
| 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 Clin Endocrinol Metab. 2007 Feb;92(2):504-8. doi: 10.1210/jc.2006-1516. Epub 2006 Nov 7. |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D001519 | Behavior |
| D003710 | Demography |
| D011154 | Population Characteristics |