NCT07335549

Brief Summary

Obesity is a multifactorial disease which has become a public health problem with increasing frequency, especially in recent years. Obesity causes many health problems with its negative effects on organs, systems, and psychosocial status. It is a serious risk factor for many diseases and also causes a significant increase in morbidity and mortality in these diseases. Although dietary treatments and medical treatment options are frequently used, surgical options are still the most effective treatment. Bariatric and metabolic surgical techniques are frequently applied, especially in patients with advanced obesity and obesity-related comorbidities. The most commonly applied bariatric metabolic surgical techniques, as in our clinic, are laparoscopic sleeve gastrectomy (LSG) and Roux-en-y gastric bypass procedures. The role of adipokines, secreted from adipose tissue and thought to play a role in the development of obesity, is quite important in the obesity mechanism, as they are effective not only in energy processes but also in metabolic processes. These adipokines secreted by adipose tissue play an active role in many mechanisms in the body, including vasoactivity, oxidative processes, immunity, lipid and glucose metabolism. Adipokines function actively in many target organs such as the pancreas, liver, and brain. Isthmin, a relatively new adipokine expressed from brown and white adipocytes, also affects many systems like other adipokines. Studies have shown that Isthmin plays an active role in glucose and lipid metabolism, and it has been reported to play a role in many metabolic processes, from insulin resistance to hepatic steatosis. The aim of this study is to investigate whether isthmin levels change before and after surgery in patients undergoing LSG for severe obesity, given that isthmin is thought to be associated with obesity and insulin resistance, particularly by affecting the appetite center in metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

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

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 2, 2026

Last Update Submit

January 2, 2026

Conditions

Keywords

Severe ObesityLaparoscopic Sleeve GastrectomyIsthminAdipokines

Outcome Measures

Primary Outcomes (1)

  • Serum Isthmin Levels' change

    Serum Isthmin Levels' change

    Preoperative and postoperative third month

Study Arms (1)

Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity

Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity

Diagnostic Test: Preoperative Serum Isthmin LevelsDiagnostic Test: Postoperative Third Month's Serum Isthmin LevelsOther: Preoperative BMIOther: Postoperative BMI

Interventions

Preoperative Serum Isthmin Levels

Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity

Postoperative Third Month's Serum Isthmin Levels

Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity

Preoperative the height and the weight of the patient will record. After that BMI will be calculated as formula "The Body Weight (kg)/(The Height (meters)x The Height (meters))

Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity

Postoperative third month's the height and the weight of the patient will record. After that BMI will be calculated as formula "The Body Weight (kg)/(The Height (meters)x The Height (meters))

Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity

Eligibility Criteria

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

BMI \> 40 kg/m2 without comorbidity who are planned for Laparoscopic Sleeve Gastrectomy

You may qualify if:

  • Being over 18 years of age
  • Being diagnosed with severe obesity
  • Patients who do not wish to participate in the study

You may not qualify if:

  • Patients under 18 years of age
  • Overweight patients with a Body Mass Index \<40 kg/m2 and no comorbidities
  • Patients with rheumatological diseases (rheumatoid arthritis, SLE, etc.)
  • Patients with chronic kidney and liver failure
  • Patients diagnosed with Diabetes Mellitus
  • Patients with malignancy
  • Patients who do not wish to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazig Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (7)

  • Lopez-Yus M, Casamayor C, Soriano-Godes JJ, Borlan S, Gonzalez-Irazabal Y, Garcia-Sobreviela MP, Garcia-Rodriguez B, Del Moral-Bergos R, Calmarza P, Artigas JM, Lorente-Cebrian S, Bernal-Monterde V, Sanz-Paris A, Arbones-Mainar JM. Isthmin-1 (ISM1), a novel adipokine that reflects abdominal adipose tissue distribution in individuals with obesity. Cardiovasc Diabetol. 2023 Dec 8;22(1):335. doi: 10.1186/s12933-023-02075-0.

    PMID: 38066623BACKGROUND
  • Dunmore SJ. Of fat mice and men: the rise of the adipokines. J Endocrinol. 2013 Jan 2;216(1):E1-2. doi: 10.1530/JOE-12-0513. Print 2013 Jan. No abstract available.

    PMID: 23160965BACKGROUND
  • Fasshauer M, Bluher M. Adipokines in health and disease. Trends Pharmacol Sci. 2015 Jul;36(7):461-70. doi: 10.1016/j.tips.2015.04.014. Epub 2015 May 25.

    PMID: 26022934BACKGROUND
  • Peri K, Eisenberg M. Review on obesity management: bariatric surgery. BMJ Public Health. 2024 Nov 27;2(2):e000245. doi: 10.1136/bmjph-2023-000245. eCollection 2024 Dec.

    PMID: 41201062BACKGROUND
  • 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
  • GBD 2019 Risk Factors Collaborators. Global burden of 87 risk factors in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1223-1249. doi: 10.1016/S0140-6736(20)30752-2.

    PMID: 33069327BACKGROUND
  • Jiang Z, Zhao M, Voilquin L, Jung Y, Aikio MA, Sahai T, Dou FY, Roche AM, Carcamo-Orive I, Knowles JW, Wabitsch M, Appel EA, Maikawa CL, Camporez JP, Shulman GI, Tsai L, Rosen ED, Gardner CD, Spiegelman BM, Svensson KJ. Isthmin-1 is an adipokine that promotes glucose uptake and improves glucose tolerance and hepatic steatosis. Cell Metab. 2021 Sep 7;33(9):1836-1852.e11. doi: 10.1016/j.cmet.2021.07.010. Epub 2021 Aug 3.

    PMID: 34348115BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Preoperative rotuine blood samples and postopoperastive third month routine control's blood samples

MeSH Terms

Conditions

ObesityOverweightObesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mehmet B Bozan, Professor

    Turkish Health Sciences University Elazig City Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proefessor, Associate MD

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

July 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations