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

NCT06071559 | Completed

• 1 other identifier: 2014/1793-31/1
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgery; Obesity Associated Disorder; Coagulation Disorder; Diabetes Complications

Keywords

Bariatric surgery; Fibrinolysis

Outcome Measures

Primary Outcomes (4)

• 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 (%)

  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)

  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)

  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)

  before surgery - 2 years after surgery

Study Arms (2)

Obesitysurgery with diabetes

OTHER

One group with obesity and concomitant type 2 diabetes

Procedure: Laparoscopic Roux-en-y gastric bypass

Obesitysurgery and non-diabetes

OTHER

One group with obesity alone

Procedure: Laparoscopic Roux-en-y gastric bypass

Interventions

Laparoscopic Roux-en-y gastric bypass PROCEDURE

Obesity surgery

Obesitysurgery and non-diabetes; Obesitysurgery with diabetes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• Ongoing treatment with anticoagulant medication
• Ongoing treatment with antiplatelet medication other than acetylsalicylic acid
• Type 1 diabetes

Sponsors & Collaborators

• Ersta Diakoni: lead
• Karolinska Institutet: collaborator

MeSH Terms

Conditions

Hemostatic Disorders; Diabetes Complications

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Anders Thorell, Professor

  Karolinska Institutet Danderyds sjukhus/Ersta sjukhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon, Clinical professor

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: October 6, 2023
• Study Start: January 1, 2015
• Primary Completion: December 31, 2021
• Study Completion: June 1, 2022
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share