E66.09 E11.90 E88.9 R73.0
Conditions
Interventions
Group 1: Children and adolescents with overweight or obesity
Nutritional intervention: Mediterranean diet, counseling, and medical history assessment at T0, T1 (after 3 months), and T2 (after 6 months
Sponsors
Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: Arm 1: - BMI > 90. percentile (Kromeyer-Hausschild) - Written informed consent of parents or guardians or of participants aged 16 years and older Arm 2: - BMI > 90. percentile (Kromeyer-Hausschild) - Participation in the KLAKS physical education program - Written informed consent of parents or guardians or of participants aged 16 years and older Arm 3: - BMI > 90. percentile (Kromeyer-Hausschild) - Diagnosed type 2 diabetes (HbA1c of 6.5–11.1%, fasting glucose = 7.0 mmol/l, or 120-minute OGTT glucose level = 7.8 mmol/l) - Written informed consent of parents or guardians or of participants aged 16 years and older Arm 4: - BMI < 90. percentile (Kromeyer-Hausschild) - Written informed consent of parents or guardians or of participants aged 16 years and older
Exclusion criteria
Exclusion criteria: Arm 1: - Syndromal obesity - Pregnancy - Chronic underlying disease that prevents participation in the study Arm 2: - Syndromal obesity - Pregnancy - Chronic underlying disease that prevents participation in the study Arm 3: - Syndromal obesity -MODY-Diabetes - Pregnancy - Chronic underlying disease that prevents participation in the study Arm 4: - Diagnosed metabolic disorder - Pregnancy - Chronic underlying disease that prevents participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change in BHI as a marker for mitochondrial function as a function of metabolic status and nutritional intervention (at T1 after 3 months and T2 after 6 months, measured using extracellular flux analysis) - Change in anthropometric parameters (BMI-SDS, WHtR, body fat percentage) due to the influence of a Mediterranean Diet or increased physical activity (at T1 and T2) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in other cardiometabolic risk markers of the Metabolic Syndrom (lipid profile, uric acid, transaminases, glucose homeostasis) - Changes in metabolic status (NBZ, insulin, HbA1c, Advanced Glycation Endproducts) - Identification of new risk parameters | — |
Countries
Germany
Contacts
Public ContactSusann Weihrauch-Blüher
Universitätsmedizin Halle (Saale)
Outcome results
None listed