Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
DISKUS study
Study hypothesis
The number of overweight children has risen staggeringly in Germany. Overweightness is associated with the metabolic syndrome and, by extension, with a high risk of cardiovascular morbidity and mortality. Up to now, attempts to treat children and adolescents have basically been limited to interventions targeting lifestyle. They have often not produced lasting effects, neither is it clear why these endeavours are shortlived. Our approach in attempting to clarify this issue is to undertake a comprehensive investigation of children and adolescents who face a high risk of the metabolic syndrome.
Ethics approval
Ethics approval received from the Ethics Committee of the University of Tuebingen on the 13th June 2007 (ref: 130/2007BO1).
Study design
Our study is a prospective, controlled, open, non-randomised investigation.
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Childhood obesity, metabolic syndrome
Intervention
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 Department of Sports Medicine (one half-day visit), including counselling by a sports medicine clinician. Sub-group: Additional investigations in 30 randomly-chosen patients: Mental Rotations Test (MRT), eye-tracking.
Months 1 - 6: Two nutritional counselling sessions focusing on the subjects of food and beverage choices, implementation in daily life. Physical activity and exercise at home (involving family, friends, recreational centre/sports club) as recommended by the sports medicine clinician.
Month 6: First interim examination (same as first visit). Visit additionally includes the analysis of a four-day eating protocol and the physical activity log book, followed by counselling. Sub-group (n = 30): Additional investigations comprise MRT and eye-tracking.
Months 7 - 12: Nutritional counselling session and/or further sports medicine instruction if required for exercise at home (involving family, friends, recreational centre/sports club) as recommended by the sports medicine clinician.
Month 12: Second interim examination (same as first visit). Visit additionally includes the analysis of a four-day eating protocol and the physical activity log book, followed by counselling.
Months 12 - 24: Observational phase: the intervention is implemented independently by the volunteer.
Month 24: Final examination (same as first visit). Visit additionally includes the analysis of a four-day eating protocol and the physical activity log book, followed by counselling.
Schematic diagram of the trial design (control group):
Preliminary examination: Presentation and examination at the Hospital for Children and Adolescent Medicine (one half-day visit).
Months 1 - 6: One nutritional counselling session focusing on the subjects of food and beverage choices, implementation in daily life.
Month 6: First interim examination (same as first visit). Visit additionally includes the analysis of a four-day eating protocol.
Months 7 - 12: Nutritional counselling session if required.
Month 12: Second interim examination (same as first visit). Visit additionally includes the analysis of a four-day eating protocol.
Months 12 - 24: Observational phase: the intervention is implemented independently by the volunteer.
Month 24: Final examination (same as first visit). Visit additionally includes the analysis of a four-day eating protocol.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 outcome measures
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.
Overall trial start date
01/02/2008
Overall trial end date
01/08/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Study group: n = 100; control group: n = 50
Participant 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
Recruitment start date
01/02/2008
Recruitment end date
01/08/2010
Locations
Countries of recruitment
Germany
Trial participating centre
University Children's Hospital
Tuebingen
72076
Germany
Funders
Funder type
Government
Funder name
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - an application for a Research Grant has been submitted
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary