Status:
RECRUITING
Metabolic Phenotyping for Personalized Obesity Therapy
Lead Sponsor:
University Hospital Schleswig-Holstein
Conditions:
Obesity and Overweight
Eligibility:
All Genders
18-70 years
Brief Summary
This study aims to develop a simple, clinically applicable method for metabolic phenotyping to personalize obesity therapy in morbidly obese individuals. The underlying concept is that the way a perso...
Detailed Description
This study is a prospective, single-center, longitudinal cohort trial designed to unravel the metabolic heterogeneity among morbidly obese individuals and to develop a clinically feasible method for m...
Eligibility Criteria
Inclusion
- Morbid obesity (BMI \> 40 kg/m²)
- Currently undergoing a multimodal obesity therapy program at the Department of Internal Medicine I at the University Hospital Schleswig-Holstein (UKSH), Campus Kiel
Exclusion
- Type 1 or Type 2 diabetes mellitus, or fasting blood glucose \>125 mg/dL, or HbA1c \>6.5%
- Conditions affecting appetite or energy expenditure (e.g., Cushing's syndrome, uncontrolled hyper-/hypothyroidism, diabetes mellitus)
- Gastrointestinal diseases that may impair nutrient absorption (e.g., inflammatory bowel disease, malabsorption syndromes, peptic ulcers)
- Psychiatric disorders that influence eating behavior (e.g., active depression, anorexia nervosa, bulimia nervosa, borderline personality disorder)
- Acute, unstable cardiovascular disease requiring hospitalization within the last 6 months (e.g., stent implantation)
- Cancer requiring treatment within the past 5 years
- Chronic kidney disease at Stage IV or worse according to NKF criteria
- Active infectious disease (e.g., HIV, hepatitis)
- Active nicotine use
- Drug use (e.g., amphetamines, cocaine, heroin, marijuana)
- Regular intense physical activity (≥1 hour of sport per day)
- Non-MRI-compatible metallic implants (e.g., joint replacements, metal plates)
- Pregnancy or breastfeeding
- Use of weight-loss medications
- Clinically relevant claustrophobia
- Any other condition not specified above that, in the judgment of the investigator, could interfere with study participation or compromise patient safety
Key Trial Info
Start Date :
September 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06874270
Start Date
September 15 2023
End Date
September 30 2027
Last Update
March 13 2025
Active Locations (1)
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1
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105