NCT07004556

Brief Summary

Obesity is a major global health concern with a rising prevalence and numerous associated comorbidities. For the treatment of severe obesity, bariatric surgery stands as the most effective procedure. Bariatric and metabolic surgical procedures are applied even in the absence of comorbidities, particularly in patients with Type-III obesity and above. Currently, the most commonly performed bariatric metabolic surgical procedures are Laparoscopic Sleeve Gastrectomy (LSG) and Roux-en-Y gastric bypass. Animal studies have shown that phoenixin (PNX) in the paraventricular, arcuate, and solitary tract nuclei contributes to regulating food intake, and its intracerebral administration in rats increased food intake. The aim of this study is to investigate whether PNX-14 levels change before and after LSG in patients undergoing the procedure for severe obesity, given the potential association of PNX-14 with obesity and insulin resistance through its influence on the appetite center in metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

May 26, 2025

Last Update Submit

January 10, 2026

Conditions

Keywords

Severe ObesityLaparoscopic Sleeve GastrectomyPhoenixin-14Obesity Surgery

Outcome Measures

Primary Outcomes (1)

  • Laparoscopic Sleeve Gastrectomy effects blood Phoenixin 14 levels

    Phoenixin 14 blood levels can be effected by surgical intervention for severe obesity (laparoscopic sleeve gastrectomy)

    June 01,2025-October 01,2025

Study Arms (1)

Selective Laparoscopic Sleeve Gastrectomy Patients

Preoperative and postoperative blood samples obtained from the patients

Diagnostic Test: Preoperative blood sampling for determining Phoenixin 14 levelsDiagnostic Test: Postoperative blood sampling for determining Phoenixin 14 levels

Interventions

In addition to routine blood draws for pre-operative preparations, 5 ml of blood will be collected.

Selective Laparoscopic Sleeve Gastrectomy Patients

In addition to routine blood draws for postoperative controls, 5 ml of blood will be collected.

Selective Laparoscopic Sleeve Gastrectomy Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severe obesity patients scheduled for selective laparoscopic sleeve gastrectomy who have no associated medical problems

You may qualify if:

  • Patients aged 18-65 years.
  • Patients with severe obesity (Body Mass Index (BMI) ≥ 40 kg/m²) with no additional comorbidities (Type III, Type IV, and Type V obesity) who are scheduled for primary LSG.
  • Patients who consent to participate in the study.

You may not qualify if:

  • Patients who do not consent to participate in the study.
  • Patients scheduled for primary obesity surgery other than LSG (e.g., Single Anastomosis Gastric Bypass, Roux-en-Y Gastric Bypass, Transit Bipartition, Single Anastomosis Sleeve Ileal Bypass, Single Anastomosis Duodeno-intestinal Bypass, Duodenal Switch).
  • Patients with a BMI ≥ 35 kg/m² with associated medical problems (e.g., Diabetes Mellitus, Asthma, Chronic Obstructive Pulmonary Disease, Ischemic Heart Disease, Hypertension).
  • Patients with a BMI ≤ 35 kg/m² who do not have a surgical indication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (12)

  • Prinz P, Scharner S, Friedrich T, Schalla M, Goebel-Stengel M, Rose M, Stengel A. Central and peripheral expression sites of phoenixin-14 immunoreactivity in rats. Biochem Biophys Res Commun. 2017 Nov 4;493(1):195-201. doi: 10.1016/j.bbrc.2017.09.048. Epub 2017 Sep 11.

    PMID: 28911868BACKGROUND
  • Akdu S, Can U, Polat E. Investigation of serum phoenixin levels in patients with hypertension. Rev Assoc Med Bras (1992). 2022 Jun 24;68(6):814-819. doi: 10.1590/1806-9282.20220153. eCollection 2022.

    PMID: 35766697BACKGROUND
  • Cundubey CR, Cam SD. Serum Phoenixin-14 levels of women with polycystic ovary syndrome increase proportionally with BMI. Eur Rev Med Pharmacol Sci. 2023 Apr;27(8):3519-3525. doi: 10.26355/eurrev_202304_32125.

    PMID: 37140302BACKGROUND
  • Mukherjee K, Unniappan S. Mouse gastric mucosal endocrine cells are sources and sites of action of Phoenixin-20. Peptides. 2021 Jul;141:170551. doi: 10.1016/j.peptides.2021.170551. Epub 2021 Apr 17.

    PMID: 33862165BACKGROUND
  • Schalla M, Prinz P, Friedrich T, Scharner S, Kobelt P, Goebel-Stengel M, Rose M, Stengel A. Phoenixin-14 injected intracerebroventricularly but not intraperitoneally stimulates food intake in rats. Peptides. 2017 Oct;96:53-60. doi: 10.1016/j.peptides.2017.08.004. Epub 2017 Aug 24.

    PMID: 28844870BACKGROUND
  • Han Y, Jia Y, Wang H, Cao L, Zhao Y. Comparative analysis of weight loss and resolution of comorbidities between laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass: A systematic review and meta-analysis based on 18 studies. Int J Surg. 2020 Apr;76:101-110. doi: 10.1016/j.ijsu.2020.02.035. Epub 2020 Mar 6.

    PMID: 32151750BACKGROUND
  • https://bmjpublichealth.bmj.com/lookup/doi/10.1136/bmjph-2023-000245

    BACKGROUND
  • Kirkil C, Aygen E, Korkmaz MF, Bozan MB. QUALITY OF LIFE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY USING BAROS SYSTEM. Arq Bras Cir Dig. 2018 Aug 16;31(3):e1385. doi: 10.1590/0102-672020180001e1385.

    PMID: 30133677BACKGROUND
  • https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight

    BACKGROUND
  • Kassir R, Debs T, Blanc P, Gugenheim J, Ben Amor I, Boutet C, Tiffet O. Complications of bariatric surgery: Presentation and emergency management. Int J Surg. 2016 Mar;27:77-81. doi: 10.1016/j.ijsu.2016.01.067. Epub 2016 Jan 22.

    PMID: 26808323BACKGROUND
  • Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery. Obes Surg. 2023 Jan;33(1):3-14. doi: 10.1007/s11695-022-06332-1.

    PMID: 36336720BACKGROUND
  • Purnell JQ. Definitions, Classification, and Epidemiology of Obesity. 2023 May 4. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK279167/

    PMID: 25905390BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidObesityOverweight

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Associate (MD)

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 4, 2025

Study Start

July 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations