Clinical trial NCT07008352: Amino Acid Metabolism Before and After Bariatric Surgery
Official title: Examination of Preoperative and Postoperative Serum Amino Acid Metabolism in Individuals Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include 50 patients diagnosed with obesity and undergoing bariatric surgery, and 50 healthy adults with normal BMI values. All participants will be recruited from Harran University Hospital.

Brief summary: This observational study aims to investigate the changes in serum amino acid metabolism before and after bariatric surgery in obese individuals. Blood samples will be collected from 50 patients at baseline (preoperative), and at 1 and 3 months postoperatively. An additional 50 healthy individuals will serve as the control group. Amino acid profiling will be conducted using LC-MS/MS. The study seeks to determine how bariatric surgery affects metabolic pathways associated with amino acid regulation.

Detailed description: Obesity is a major global health problem that significantly increases the risk of metabolic disorders. Bariatric surgery is one of the most effective interventions for sustained weight loss in morbidly obese patients. However, the metabolic effects of such surgery on amino acid profiles are not fully understood.

In this prospective observational study, a total of 100 participants will be enrolled: 50 patients undergoing bariatric surgery and 50 healthy controls. Serum samples will be collected from the patient group preoperatively, and at 1 and 3 months after surgery. The control group will provide one-time blood samples.

All serum samples will be centrifuged and stored at -80°C until analysis. Free amino acid profiles will be determined using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The primary outcome is to assess the change in amino acid concentrations over time in surgical patients, and to compare them with healthy controls. Secondary analyses will explore correlations between amino acid levels and body mass index (BMI). Data analysis will be performed using SPSS and MetaboAnalyst 5.0.

This study will help clarify how bariatric surgery influences amino acid metabolism and may offer insights into the metabolic mechanisms underlying postoperative recovery and weight regulation.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Diagnosed with obesity and scheduled for bariatric surgery (study group)
* Healthy individuals with normal BMI (control group)

Exclusion Criteria:

* Age \<18 years
* History of metabolic or chronic systemic disease
* Pregnancy or lactation

Primary outcomes:
measure: Change in serum free amino acid levels after bariatric surgery
timeFrame: Preoperative (baseline), 1 month postoperative, 3 months postoperative
Secondary outcomes:
measure: Correlation between serum amino acid levels and body mass index (BMI)
timeFrame: Preoperative (baseline), 1 month postoperative, 3 months postoperative
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Veli Fahri Pehlivan
Study officials:
References: