NCT07008352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

June 11, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

May 29, 2025

Last Update Submit

November 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Preoperative (baseline), 1 month postoperative, 3 months postoperative

Secondary Outcomes (1)

  • Correlation between serum amino acid levels and body mass index (BMI)

    Preoperative (baseline), 1 month postoperative, 3 months postoperative

Study Arms (2)

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.

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.

Procedure: Blood sample collection for amino acid profiling

Interventions

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 1: Bariatric surgery patients (n=50)Group 2: Healthy control participants (n=50)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veli Fahri Pehlivan

Sanliurfa, 63100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples with DNA or without DNA will be retained

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 6, 2025

Study Start

June 11, 2025

Primary Completion

October 2, 2025

Study Completion

November 3, 2025

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations