- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07008352
- Original Trial
Amino Acid Metabolism Before and After Bariatric Surgery
Examination of Preoperative and Postoperative Serum Amino Acid Metabolism in Individuals Undergoing Bariatric Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Sanliurfa, Turkey (Türkiye), 63100
- Veli Fahri Pehlivan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1: Bariatric surgery patients (n=50)
Participants in this group are adults (≥18 years old) with obesity who are scheduled to undergo bariatric surgery at Harran University Hospital.
Blood samples will be collected at three time points: before surgery (baseline), and at 1 and 3 months postoperatively.
Serum will be separated and stored at -80°C for subsequent amino acid profiling using LC-MS/MS.
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Blood samples (5 mL) will be collected from participants in both groups.
In the bariatric surgery group, samples will be collected at three time points: preoperatively, and at 1 and 3 months postoperatively.
For the control group, a single sample will be obtained.
Serum will be separated, stored at -80°C, and analyzed for free amino acid profiles using LC-MS/MS.
|
|
Group 2: Healthy control participants (n=50)
Participants in this group are healthy adults (≥18 years old) with no known history of obesity or chronic metabolic disease.
A single blood sample will be collected at baseline.
Serum samples will be analyzed using LC-MS/MS to determine amino acid profiles, which will be compared to those of the bariatric surgery group.
|
Blood samples (5 mL) will be collected from participants in both groups.
In the bariatric surgery group, samples will be collected at three time points: preoperatively, and at 1 and 3 months postoperatively.
For the control group, a single sample will be obtained.
Serum will be separated, stored at -80°C, and analyzed for free amino acid profiles using LC-MS/MS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in serum free amino acid levels after bariatric surgery
Time Frame: Preoperative (baseline), 1 month postoperative, 3 months postoperative
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Amino acid concentrations will be measured in serum samples collected from bariatric surgery patients at baseline, 1 month, and 3 months postoperatively using LC-MS/MS.
The outcome will assess time-dependent changes in the amino acid profile within the same individuals.
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Preoperative (baseline), 1 month postoperative, 3 months postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between serum amino acid levels and body mass index (BMI)
Time Frame: Preoperative (baseline), 1 month postoperative, 3 months postoperative
|
This outcome will evaluate the relationship between changes in serum amino acid concentrations and BMI values measured at baseline, 1 month, and 3 months after bariatric surgery.
Pearson or Spearman correlation analyses will be performed.
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Preoperative (baseline), 1 month postoperative, 3 months postoperative
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gerger
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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