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

ISRCTN	ISRCTN09100243
DOI	https://doi.org/10.1186/ISRCTN09100243
Secondary identifying numbers	N/A

Submission date: 12/12/2007
Registration date: 25/01/2008
Last edited: 15/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Ranke
Scientific

University Children's Hospital
Hoppe-Seyler-Strasse 1
Tuebingen
72076
Germany

Study information

Study design	Our study is a prospective, controlled, open, non-randomised investigation.
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	DISKUS study
Study objectives	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(s)	Ethics approval received from the Ethics Committee of the University of Tuebingen on the 13th June 2007 (ref: 130/2007BO1).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2008
Completion date	01/08/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	Study group: n = 100; control group: n = 50
Key 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
Key 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
Date of first enrolment	01/02/2008
Date of final enrolment	01/08/2010

Locations

Countries of recruitment

Germany

Study participating centre

University Children's Hospital

Tuebingen
72076
Germany

Sponsor information

University Children's Hospital of Tuebingen (Germany) - Section of Pediatric Endocrinology
Hospital/treatment centre

c/o Michael B. Ranke, M.D.
Hoppe-Seyler-Strasse 1
Tuebingen
72076
Germany

"ROR"	https://ror.org/03esvmb28

Funders

Funder type

Government

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - an application for a Research Grant has been submitted

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan