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Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function. (FIBRINO)

Primary Purpose

Surgery, Obesity Associated Disorder, Coagulation Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Roux-en-y gastric bypass
Sponsored by
Ersta Diakoni
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Surgery focused on measuring Bariatric surgery, Fibrinolysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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.) Exclusion criteria: Ongoing treatment with anticoagulant medication Ongoing treatment with antiplatelet medication other than acetylsalicylic acid Type 1 diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Obesitysurgery with diabetes

    Obesitysurgery and non-diabetes

    Arm Description

    One group with obesity and concomitant type 2 diabetes

    One group with obesity alone

    Outcomes

    Primary Outcome Measures

    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 (%)
    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)
    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)
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2023
    Last Updated
    October 2, 2023
    Sponsor
    Ersta Diakoni
    Collaborators
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06071559
    Brief Title
    Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.
    Acronym
    FIBRINO
    Official Title
    Effects of Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    December 31, 2021 (Actual)
    Study Completion Date
    June 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ersta Diakoni
    Collaborators
    Karolinska Institutet

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgery, Obesity Associated Disorder, Coagulation Disorder, Diabetes Complications
    Keywords
    Bariatric surgery, Fibrinolysis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Obesitysurgery with diabetes
    Arm Type
    Other
    Arm Description
    One group with obesity and concomitant type 2 diabetes
    Arm Title
    Obesitysurgery and non-diabetes
    Arm Type
    Other
    Arm Description
    One group with obesity alone
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Roux-en-y gastric bypass
    Intervention Description
    Obesity surgery
    Primary Outcome Measure Information:
    Title
    Blood tests for endothelial function comparing two years after surgery with baseline (below referred to as "changes in").
    Description
    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 (%)
    Time Frame
    before surgery - 2 years after surgery
    Title
    Blood tests for fibrinolysis comparing two years after surgery with baseline (below referred to as "changes in").
    Description
    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)
    Time Frame
    before surgery - 2 years after surgery
    Title
    Blood tests for inflammation comparing two years after surgery with baseline (below referred to as "changes in").
    Description
    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)
    Time Frame
    before surgery - 2 years after surgery
    Title
    Blood tests for extracellular vesicles comparing two years after surgery with baseline (below referred to as "changes in").
    Description
    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)
    Time Frame
    before surgery - 2 years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: 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.) Exclusion criteria: Ongoing treatment with anticoagulant medication Ongoing treatment with antiplatelet medication other than acetylsalicylic acid Type 1 diabetes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anders Thorell, Professor
    Organizational Affiliation
    Karolinska Institutet Danderyds sjukhus/Ersta sjukhus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.

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