Obesity, MorbidNCT07008352
Amino Acid Metabolism Before and After Bariatric Surgery
An observational study of Obesity, Morbid, run by Harran University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Blood sample collection for amino acid profiling
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2025to 3 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years
- Diagnosed with obesity and scheduled for bariatric surgery (study group)
- Healthy individuals with normal BMI (control group)
Who cannot join
- Age <18 years
- History of metabolic or chronic systemic disease
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Preoperative and Postoperative Serum Amino Acid Metabolism in Individuals Undergoing Bariatric Surgery
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.
Read the 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.
- Conditions
- Obesity, Morbid
- Being tested
- Blood sample collection for amino acid profiling
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collection for amino acid profilingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood sample collection for amino acid profiling | |
| 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. Receives: Procedure: Blood sample collection for amino acid profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum free amino acid levels after bariatric surgery
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.
Measured: Preoperative (baseline), 1 month postoperative, 3 months postoperative
Secondary outcomes (1)
Correlation between serum amino acid levels and body mass index (BMI)
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.
Measured: Preoperative (baseline), 1 month postoperative, 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start11 Jun 2025
- Primary completion2 Oct 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faik TATLI, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008352
- Sponsor's protocol ID
- Gerger
- Status last verified
- Nov 2025
- First submitted
- 29 May 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Preoperative and Postoperative Serum Amino Acid Metabolism in Individuals Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07008352
- Acronym / sponsor ID
- Gerger
- Conditions
- Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Bariatric surgery patients (n=50) | – | Procedure: Blood sample collection for amino acid profilingParticipants 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. |
| Group 2: Healthy control participants (n=50) | – | Procedure: Blood sample collection for amino acid profilingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Diagnosed with obesity and scheduled for bariatric surgery (study group)
- Healthy individuals with normal BMI (control group)
Key exclusion criteria (3 listed)
- Age <18 years
- History of metabolic or chronic systemic disease
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collection for amino acid profilingBlood 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. | Procedure or surgery | Group 1: Bariatric surgery patients (n=50), Group 2: Healthy control participants (n=50) |
Primary outcome
Change in serum free amino acid levels after bariatric surgery
Time frame: Preoperative (baseline), 1 month postoperative, 3 months postoperative
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.
1 secondary outcome
Correlation between serum amino acid levels and body mass index (BMI)
Time frame: Preoperative (baseline), 1 month postoperative, 3 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum free amino acid levels after bariatric surgery (time frame: Preoperative (baseline), 1 month postoperative, 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.