SurgeryFIBRINONCT06071559
Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.
A study testing Laparoscopic Roux-en-y gastric bypass in people with Surgery and Obesity Associated Disorder, run by Ersta Diakoni.
Trial summary
The goal of this prospective cohort study is to examine circulating biomarkers before and after weight loss in patients with obesity, with or without concomitant diabetes, undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgery, Obesity Associated Disorder, Coagulation Disorder
- What is being tested?
- Laparoscopic Roux-en-y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jun 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old
- Planned for Roux-en-y gastric bypass surgery
- Obesity fulfilling criteria for bariatric surgery (according to the European Association for the Study of Obesity guidelines, ref. Yumuk et al. European Guidelines for Obesity Management in Adults. Obes Facts 2015;8:402-42.)
Who cannot join
- Ongoing treatment with anticoagulant medication
- Ongoing treatment with antiplatelet medication other than acetylsalicylic acid
- Type 1 diabetes
About this study
Official title: Effects of Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.
The goal of this prospective cohort study is to examine circulating biomarkers before and after weight loss in patients with obesity, with or without concomitant diabetes, undergoing bariatric surgery. The main questions that are being addressed are:
- Do biomarkers of hemostasis, including coagulation, fibrinolysis, and platelet function improve following surgery and if so, is that improvement more pronounced in patients with diabetes?
- Do biomarkers of endothelial function and other aspects of vascular function improve following surgery and if so, is that improvement more pronounced in patients with diabetes?
- Do biomarkers of inflammation, including markers of adipocyte function, improve following surgery and if so, is that improvement more pronounced in patients with diabetes?
- The possible role of circulating extracellular vesicles reflecting biological functions above will also be investigated (optional) Participants will be asked to attend in total five study visits before and after surgery including a final visit at two years post-surgery. Comparisons will be performed within- as well as between groups.
Read the detailed description
In this single centre, prospective, parallel group, cohort study, patients meeting the eligibility criteria are recruited at the department of surgery at Ersta hospital, Stockholm, Sweden. Patients with obesity and type 2 diabetes (T2D) are matched for age and sex with the group of patients with obesity without T2D. During the study the participants attend five study visits: at baseline, at the morning of surgery (after two weeks of low calory diet), 6 weeks, 1 year and 2 years after surgery. At each study visit a nurse records blood pressure, weight, height, and waist/hip circumferences. In addition, the nurse recalls the medical history and any medication use including contraceptive hormones and analgesics. Fat mass is determined using bioelectric impedance. Venous blood samples are collected with the patients in the supine position after overnight fasting and at least 20 minutes of rest. For later analyses, 25 mL of blood is collected in citrate tubes and centrifuged for 20 min at 2000 x g in room temperature. Plasma aliquots are subsequently stored at minus 80 degrees Celsius. Blood test regarding values at baseline (not the primary outcome variables) will be analysed at the local hospital laboratory. Examples of those basic variables are concentrations of glucose, insulin, blood cell counts and lipids.
- Being tested
- Laparoscopic Roux-en-y gastric bypass
- Keywords
- Bariatric surgery, Fibrinolysis
- Medical subject headings
- Hemostatic Disorders, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux-en-y gastric bypassProcedure or surgery
Obesity surgery
| Study group | Role | What they receive |
|---|---|---|
| Obesitysurgery with diabetes | Other | One group with obesity and concomitant type 2 diabetes Receives: Procedure: Laparoscopic Roux-en-y gastric bypass |
| Obesitysurgery and non-diabetes | Other | One group with obesity alone Receives: Procedure: Laparoscopic Roux-en-y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood tests for endothelial function comparing two years after surgery with baseline (below referred to as "changes in").
Outcome measure:
- Change in Hyaluronan (ng/ml)
- Change in Syndacan-1 (ng/ml)
- Change in E-selectin (ng/ml)
- Change in Thrombomodulin (pg/ml)
- Change in von Willebrand factor (%)
Measured: before surgery - 2 years after surgery
Blood tests for fibrinolysis comparing two years after surgery with baseline (below referred to as "changes in").
Outcome measure:
- Change in PAI-1 activity (IU/ml)
- Change in Fibrinogen (pg/ml)
- Change in tPA activity (IU/ml)
- Change in PAP complex (ng/ml)
- Change in turbidimetric values - LagC (s)
- Change in turbidimetric values - LagL (s)
- Change in turbidimetric values - MaxAbsC (au)
- Change in turbidimetric values - MaxAbsL (au
- Change in turbidimetric values - Lys50MA (s)
- Change in turbidimetric values - CRC (au/s)
- Change in turbidimetric values - CRL (au/s)
Measured: before surgery - 2 years after surgery
Blood tests for inflammation comparing two years after surgery with baseline (below referred to as "changes in").
Outcome measure:
- Change in high sensitivity CRP (microg/ml)
- Change in soluble IL6 receptor (ng/mL)
- Change in IL6 (pg/mL)
- Change in soluble gp130 (ng/mL)
- Change in TNFalfa (pg/ml)
Measured: before surgery - 2 years after surgery
Blood tests for extracellular vesicles comparing two years after surgery with baseline (below referred to as "changes in").
Exploratory analyses of extracellular vesicles (EV) in plasma using flow cytometry. EV exposing antigens of cell specific origin and/or biologically active molecules will be assessed. Outcome measure: Change in number of EVs (number of EV/micoL)
Measured: before surgery - 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jan 2015
- Primary completion31 Dec 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ersta Diakoni
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Anders Thorell, Ersta Diakoni
- Investigators
- Anders Thorell, Professor, Principal investigator, Karolinska Institutet Danderyds sjukhus/Ersta sjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071559
- Sponsor's protocol ID
- 2014/1793-31/1
- Acronym
- FIBRINO
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2023
- Last updated
- 6 Oct 2023
- 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 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.
- ClinicalTrials.gov ID
- NCT06071559
- Acronym / sponsor ID
- FIBRINO / 2014/1793-31/1
- Keywords
- Bariatric surgery, Fibrinolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ersta DiakoniUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 6 Oct 2023 (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.
The goal of this prospective cohort study is to examine circulating biomarkers before and after weight loss in patients with obesity, with or without concomitant diabetes, undergoing bariatric surgery. The main questions that are being addressed are:
- Do biomarkers of hemostasis, including coagulation, fibrinolysis, and platelet function improve following surgery and if so, is that improvement more pronounced in patients with diabetes?
- Do biomarkers of endothelial function and other aspects of vascular function improve following surgery and if so, is that improvement more pronounced in patients with diabetes?
- Do biomarkers of inflammation, including markers of adipocyte function, improve following surgery and if so, is that improvement more pronounced in patients with diabetes?
- The possible role of circulating extracellular vesicles reflecting biological functions above will also be investigated (optional) Participants will be asked to attend in total five study visits before and after surgery including a final visit at two years post-surgery. Comparisons will be performed within- as well as between groups.
Detailed description
In this single centre, prospective, parallel group, cohort study, patients meeting the eligibility criteria are recruited at the department of surgery at Ersta hospital, Stockholm, Sweden. Patients with obesity and type 2 diabetes (T2D) are matched for age and sex with the group of patients with obesity without T2D. During the study the participants attend five study visits: at baseline, at the morning of surgery (after two weeks of low calory diet), 6 weeks, 1 year and 2 years after surgery. At each study visit a nurse records blood pressure, weight, height, and waist/hip circumferences. In addition, the nurse recalls the medical history and any medication use including contraceptive hormones and analgesics. Fat mass is determined using bioelectric impedance. Venous blood samples are collected with the patients in the supine position after overnight fasting and at least 20 minutes of rest. For later analyses, 25 mL of blood is collected in citrate tubes and centrifuged for 20 min at 2000 x g in room temperature. Plasma aliquots are subsequently stored at minus 80 degrees Celsius. Blood test regarding values at baseline (not the primary outcome variables) will be analysed at the local hospital laboratory. Examples of those basic variables are concentrations of glucose, insulin, blood cell counts and lipids.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesitysurgery with diabetes | Other | Procedure: Laparoscopic Roux-en-y gastric bypassOne group with obesity and concomitant type 2 diabetes |
| Obesitysurgery and non-diabetes | Other | Procedure: Laparoscopic Roux-en-y gastric bypassOne group with obesity alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years old
- Planned for Roux-en-y gastric bypass surgery
- Obesity fulfilling criteria for bariatric surgery (according to the European Association for the Study of Obesity guidelines, ref. Yumuk et al. European Guidelines for Obesity Management in Adults. Obes Facts 2015;8:402-42.)
Key exclusion criteria (3 listed)
- Ongoing treatment with anticoagulant medication
- Ongoing treatment with antiplatelet medication other than acetylsalicylic acid
- Type 1 diabetes
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 |
|---|---|---|
| Laparoscopic Roux-en-y gastric bypassObesity surgery | Procedure or surgery | Obesitysurgery and non-diabetes, Obesitysurgery with diabetes |
Primary outcome
Blood tests for endothelial function comparing two years after surgery with baseline (below referred to as "changes in").
Time frame: before surgery - 2 years after surgery
Outcome measure: * Change in Hyaluronan (ng/ml) * Change in Syndacan-1 (ng/ml) * Change in E-selectin (ng/ml) * Change in Thrombomodulin (pg/ml) * Change in von Willebrand factor (%)
Blood tests for fibrinolysis comparing two years after surgery with baseline (below referred to as "changes in").
Time frame: before surgery - 2 years after surgery
Outcome measure: * Change in PAI-1 activity (IU/ml) * Change in Fibrinogen (pg/ml) * Change in tPA activity (IU/ml) * Change in PAP complex (ng/ml) * Change in turbidimetric values - LagC (s) * Change in turbidimetric values - LagL (s) * Change in turbidimetric values - MaxAbsC (au) * Change in turbidimetric values - MaxAbsL (au * Change in turbidimetric values - Lys50MA (s) * Change in turbidimetric values - CRC (au/s) * Change in turbidimetric values - CRL (au/s)
Blood tests for inflammation comparing two years after surgery with baseline (below referred to as "changes in").
Time frame: before surgery - 2 years after surgery
Outcome measure: * Change in high sensitivity CRP (microg/ml) * Change in soluble IL6 receptor (ng/mL) * Change in IL6 (pg/mL) * Change in soluble gp130 (ng/mL) * Change in TNFalfa (pg/ml)
Blood tests for extracellular vesicles comparing two years after surgery with baseline (below referred to as "changes in").
Time frame: before surgery - 2 years after surgery
Exploratory analyses of extracellular vesicles (EV) in plasma using flow cytometry. EV exposing antigens of cell specific origin and/or biologically active molecules will be assessed. Outcome measure: Change in number of EVs (number of EV/micoL)
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 6 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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.
Anders Thorell, Professor principal investigator
Karolinska Institutet Danderyds sjukhus/Ersta sjukhus
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Roux-en-y gastric bypass in people with Surgery and Obesity Associated Disorder, run by Ersta Diakoni.
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 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Blood tests for endothelial function comparing two years after surgery with baseline (below referred to as "changes in"). (time frame: before surgery - 2 years after surgery). The study lists 4 primary outcomes in all. 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 6 Oct 2023.