NCT06874270

Metabolic Phenotyping for Personalized Obesity Therapy

Recruiting now Last updated 13 March 2025

What this trial tests

trial in Obesity and Overweight in 80 participants. Currently enrolling.

Timeline

15 September 2023

Primary endpoint
30 September 2026

30 September 2027

Quick facts

Lead sponsor	University Hospital Schleswig-Holstein
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	80
Start date	15 September 2023
Primary completion	30 September 2026
Estimated completion	30 September 2027
Sites	1 location across Germany

Conditions studied

• Obesity and Overweight — all drugs for Obesity and Overweight →

Sponsor

University Hospital Schleswig-Holstein

Who can join

Adults 18 to 70, any sex, with Obesity and Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 person's resting metabolic rate (RMR) responds to a 24-hour fast can help distinguish between two metabolic phenotypes. Individuals with a "thrifty" metabolism show a significant drop in RMR during fasting, which may make them less responsive to conventional weight loss interventions. In contrast, those with a "spendthrift" metabolism exhibit little to no drop-or even a slight increase-in RMR, suggesting they may lose weight more readily.

The trial is designed as a prospective, single-center, longitudinal cohort study involving 20 morbidly obese patients (BMI \>40 kg/m²) who are already participating in a multimodal obesity therapy program. The study is divided into three phases. In the baseline phase, participants undergo comprehensive screening, which includes physical examinations, blood tests, and body composition assessments. RMR is measured using indirect calorimetry both before and after a 24-hour fasting period, and a device (Lumen™) is used to assess whether the body is primarily burning carbohydrates or fats.

After the fasting measurements, participants perform a low-protein meal test by consuming a specially calibrated chocolate beverage. Their RMR is then monitored at several time points to determine the energy required for digestion. Following this, the study moves into the very-low-calorie diet (VLCD) phase, where participants consume approximately 800 kcal per day using formula meals tailored to meet their nutritional needs despite the calorie restriction. During this 12-week phase, changes in body weight, composition, and metabolic parameters are closely monitored.

The final phase of the study is a 12-week weight maintenance period, during which the focus is on sustaining the achieved weight loss. In addition to RMR and dietary assessments, advanced techniques such as metabolomics are employed. Blood, urine, and saliva samples are collected to analyze metabolic profiles and identify potential hormonal biomarkers-such as leptin, FGF21, and adrenaline-that could further differentiate the "thrifty" and "spendthrift" phenotypes. Body composition is also assessed using methods like bioimpedance analysis (BIA), quantitative magnetic resonance imaging (qMR), and air displacement plethysmography (BodPod).

By correlating the changes in RMR with metabolic and hormonal markers, the study tests the hypothesis that individuals with a marked RMR decrease during fasting (the "thrifty" phenotype) may experience less weight loss during a hypocaloric diet compared to those with minimal RMR change (the "spendthrift" phenotype). If validated, this approach could allow clinicians to predict weight loss outcomes more accurately and tailor obesity treatments to the individual's unique metabolic profile.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunometabolic Interactions in Obesity: Implications for Therapeutic Strategies.
   Fei Q, Huang J, He Y, Zhang Y, et al · · 2025 · cited 3× · PMID 40564149 · DOI 10.3390/biomedicines13061429