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
About this trial
This is an interventional basic science trial for Surgery focused on measuring Bariatric surgery, Fibrinolysis
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
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
NCT ID
NCT06071559
First Posted
April 13, 2023
Last Updated
October 2, 2023
Sponsor
Ersta Diakoni
Collaborators
Karolinska Institutet
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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