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Completed

NCT Number: NCT06071559

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.

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Key information

Conditions

Surgery Cardiovascular Diseases Coagulation Disorder Diabetes Complications Diabetes Mellitus Endocrine System Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Obesity Associated Disorder Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Roux-en-Y Gastric Bypass

Procedure

Obesity surgery

Primary outcomes

  1. 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 (%)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Ersta Diakoni

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: FIBRINO

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Oct 6, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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