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

Investigation of overweight/adipose children and adolescents who face a high risk of insulin resistance: dietary intervention, exercise treatment and pre- and post-treatment status in the DISKUS study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09100243

Enrollment

150

Registered

2008-01-25

Start date

2008-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Schematic diagram of the trial design (intervention group): Preliminary examination: Presentation and examination at the Hospital for Children and Adolescent Medicine (one half-day visit) and at the D

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026