Obesity & OverweightNCT07335549
Istmin Levels in Laparoscopik Sleeve Gastrectomy
An observational study of Obesity & Overweight and Sleeve Gastrectomy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Sleeve Gastrectomy, Adipokines
- What is being tested?
- Preoperative Serum Isthmin Levels, Postoperative Third Month's Serum Isthmin Levels and Preoperative BMI
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jan 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: BMI > 40 kg/m2 without comorbidity who are planned for Laparoscopic Sleeve Gastrectomy
Who may be able to join
- Being over 18 years of age
- Being diagnosed with severe obesity
- Patients who do not wish to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazig Fethi Sekin City Hospital
Elâzığ, 23100
About this study
Official title: Effect of Laparoscopic Sleeve Gastrectomy on Blood Isthmın Levels: A Prospective Cohort Study
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.
Read more
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.
Read the detailed description
Obesity is a multifactorial disease caused by genetic, environmental, and psychiatric factors. Having existed for hundreds of years, obesity has become a public health problem with increasing frequency, especially in recent years. According to WHO data, in 2016 there were 1.9 billion overweight and 650 million obese patients worldwide, and in 2022, there were 2.5 billion overweight and 890 million obese patients. This massive increase in obesity incidence in such a short time highlights that obesity is a very serious problem worldwide. According to this data, approximately 43% of the adult population over 18 years of age is overweight. This data reiterates the fact that obesity is a widespread problem with a rapidly increasing trend globally.
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. Studies estimate that approximately 5 million people die worldwide due to non-communicable diseases such as cardiovascular diseases, diabetes, cancer, neurological disorders, chronic respiratory diseases, and digestive disorders related to obesity.
Today, many treatment methods are available for obesity. 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. For this purpose, numerous bariatric metabolic surgical techniques have been developed. Currently, 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. They exert their effects through paracrine and autocrine pathways. 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.
- Conditions
- Obesity & Overweight, Sleeve Gastrectomy, Adipokines
- Being tested
- Preoperative Serum Isthmin Levels, Postoperative Third Month's Serum Isthmin Levels, Preoperative BMI, Postoperative BMI
- Keywords
- Severe Obesity, Laparoscopic Sleeve Gastrectomy, Isthmin, Adipokines
- Medical subject headings
- Obesity, Overweight, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Serum Isthmin LevelsDiagnostic test
Preoperative Serum Isthmin Levels
Postoperative Third Month's Serum Isthmin LevelsDiagnostic test
Postoperative Third Month's Serum Isthmin Levels
Preoperative BMIOther
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))
Postoperative BMIOther
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))
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity | Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity Receives: Diagnostic Test: Preoperative Serum Isthmin Levels; Diagnostic Test: Postoperative Third Month's Serum Isthmin Levels; Other: Preoperative BMI; Other: Postoperative BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Isthmin Levels' change
Serum Isthmin Levels' change
Measured: Preoperative and postoperative third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jul 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Buğra Bozan, Saglik Bilimleri Universitesi
- Investigators
- Mehmet B Bozan, Professor, Study director, Turkish Health Sciences University Elazig City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335549
- Sponsor's protocol ID
- EFSCH1
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38066623Dunmore 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.
PubMed 23160965Fasshauer 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.
PubMed 26022934Peri 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.
PubMed 41201062Kirkil 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.
PubMed 30133677GBD 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.
PubMed 33069327Jiang 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.
PubMed 34348115
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic Sleeve Gastrectomy on Blood Isthmın Levels: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07335549
- Acronym / sponsor ID
- EFSCH1
- Conditions
- Obesity & Overweight, Sleeve Gastrectomy, Adipokines
- Keywords
- Severe Obesity, Laparoscopic Sleeve Gastrectomy, Isthmin, Adipokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 13 Jan 2026 (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.
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.
Detailed description
Obesity is a multifactorial disease caused by genetic, environmental, and psychiatric factors. Having existed for hundreds of years, obesity has become a public health problem with increasing frequency, especially in recent years. According to WHO data, in 2016 there were 1.9 billion overweight and 650 million obese patients worldwide, and in 2022, there were 2.5 billion overweight and 890 million obese patients. This massive increase in obesity incidence in such a short time highlights that obesity is a very serious problem worldwide. According to this data, approximately 43% of the adult population over 18 years of age is overweight. This data reiterates the fact that obesity is a widespread problem with a rapidly increasing trend globally.
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. Studies estimate that approximately 5 million people die worldwide due to non-communicable diseases such as cardiovascular diseases, diabetes, cancer, neurological disorders, chronic respiratory diseases, and digestive disorders related to obesity.
Today, many treatment methods are available for obesity. 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. For this purpose, numerous bariatric metabolic surgical techniques have been developed. Currently, 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. They exert their effects through paracrine and autocrine pathways. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity | – | Diagnostic Test: Preoperative Serum Isthmin Levels, Diagnostic Test: Postoperative Third Month's Serum Isthmin Levels, Other: Preoperative BMI, Other: Postoperative BMILaparoscopic Sleeve Gastrectomy Patients for Severe Obesity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- BMI > 40 kg/m2 without comorbidity who are planned for Laparoscopic Sleeve Gastrectomy
Key inclusion criteria (3 listed)
- Being over 18 years of age
- Being diagnosed with severe obesity
- Patients who do not wish to participate in the study
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Preoperative Serum Isthmin LevelsPreoperative Serum Isthmin Levels | Diagnostic test | Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity |
| Postoperative Third Month's Serum Isthmin LevelsPostoperative Third Month's Serum Isthmin Levels | Diagnostic test | Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity |
| Preoperative BMIPreoperative 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)) | Other | Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity |
| Postoperative BMIPostoperative 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)) | Other | Laparoscopic Sleeve Gastrectomy Patients for Severe Obesity |
Primary outcome
Serum Isthmin Levels' change
Time frame: Preoperative and postoperative third month
Serum Isthmin Levels' change
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 13 Jan 2026.
- Background: PubMed 38066623Lopez-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.
- Background: PubMed 23160965Dunmore 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.
- Background: PubMed 26022934Fasshauer 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.
- Background: PubMed 41201062Peri 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.
- Background: PubMed 30133677Kirkil 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.
- Background: PubMed 33069327GBD 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.
- Background: PubMed 34348115Jiang 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.
- 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.
Mehmet B Bozan, Professor study director
Turkish Health Sciences University Elazig City Hospital
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 & Overweight and Sleeve Gastrectomy, run by Saglik Bilimleri Universitesi 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 7 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 13 Jan 2026. 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?
Serum Isthmin Levels' change (time frame: Preoperative and postoperative third month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07335549, which also lists 7 linked publications.
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 13 Jan 2026.