Obesity in children and adolescents with a high risk of insulin resistance

Completed

Conditions: Childhood obesity, metabolic syndrome
Nutritional, Metabolic, Endocrine
Childhood obesity

Registration Number: ISRCTN09100243

Lead Sponsor: niversity Children's Hospital of Tuebingen (Germany) - Section of Pediatric Endocrinology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Overweight (Body Mass Index [BMI] greater than 90th centile) or obese (BMI greater than 97th centile)
2. Children and adolescents between the ages of 6 and 18 years
3. One or more of the following criterias:
3.1. Extreme obesity (BMI greater than 99.5 centile of age- and sex-matched references)
3.2. First-degree relative with type 2 diabetes/diabetes during pregnancy or two grandparents with type 2 diabetes
3.3. Neonatal size either small or large for gestational age (birth weight or birth length less than 5th/greater than 95th centile)
3.4. Acanthosis nigricans
3.5. Polycystic ovary syndrome
3.6. Children and adolescents with established glucose tolerance impairment, abnormal levels of fasting glucose, type 2 diabetes

Exclusion Criteria

1. Type 1 diabetes
2. Eating disorder
3. Pregnancy
4. Neoplasm or severe systemic disease
5. Cardiovascular disease
6. Mental retardation
7. Mental health problem

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Significant yearly changes in the BMI (Standard Deviation Score [SDS])<br>2. Significant yearly changes in the level of fasting insulin (HOmeostasis Model Assessment of Insulin Resistance [HOMA-IR])<br><br>Outcomes measured at baseline and months 6, 12 and 24.

Secondary Outcome Measures

Name	Time	Method
1. Improvements in physical fitness:<br>1.1. Ventilatory threshold<br>1.2. Period of total load<br>1.3. Subjective fatigue<br>1.4. Maximum heart rate<br>1.5. Watt-max test<br>1.6. Oxygen uptake<br>2. Lowering of the systolic/diastolic blood pressure to below the 95th centile<br>3. Improvements in the levels of High Density Lipoprotein (HDL) cholesterol, lowering of levels triglyceride levels<br>4. Reduction or reversal of pathological status of thickness and proportion of abdominal fat/skinfold thickness<br>5. Boost in general vigour<br>6. Improvement of well-being and mood, enhancement of health-related quality of life<br><br>Outcomes measured at baseline and months 6, 12 and 24.