Personalized obesity therapy based on metabolic phenotyping
Establishment of a Specific Metabolic Phenotyping for the Personalization of Obesity Therapy in Morbidly Obese Individuals
This study is testing a new way to personalize weight loss treatment for very obese people by looking at how their metabolism reacts to fasting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital Schleswig-Holstein Academic / other |
| Locations | 1 site (Kiel, Schleswig-Holstein) |
| Trial ID | NCT06874270 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a clinically applicable method for metabolic phenotyping to personalize obesity therapy in morbidly obese individuals. It focuses on how resting metabolic rate (RMR) responds to a 24-hour fast to distinguish between 'thrifty' and 'spendthrift' metabolic phenotypes. The study involves a longitudinal cohort of 20 morbidly obese patients who are already enrolled in a multimodal obesity therapy program, with extensive assessments of body composition and metabolic status. Participants undergo comprehensive screening and evaluations to characterize their metabolic responses, which may guide personalized treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are morbidly obese individuals (BMI > 40 kg/m²) currently participating in a multimodal obesity therapy program.
Not a fit: Patients with conditions affecting metabolism or energy expenditure, such as diabetes or severe psychiatric disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized obesity treatments based on individual metabolic responses.
How similar studies have performed: While metabolic phenotyping is a growing area of interest, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Kiel, Schleswig-Holstein
- University Hospital Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Tim Hollstein, PD Dr. med.
- Email: tim.hollstein@uksh.de
- Phone: +4943150022000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.