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

Sponsor

Ersta Diakoni (Other)

Overall Status

Completed

CT.gov ID

NCT06071559

Collaborator

Karolinska Institutet (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Obesity Associated Disorder Coagulation Disorder Diabetes Complications	Procedure: Laparoscopic Roux-en-y gastric bypass	N/A

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

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Obesitysurgery with diabetes One group with obesity and concomitant type 2 diabetes	Procedure: Laparoscopic Roux-en-y gastric bypass Obesity surgery
Other: Obesitysurgery and non-diabetes One group with obesity alone	Procedure: Laparoscopic Roux-en-y gastric bypass Obesity surgery

Arm

Intervention/Treatment

Other: Obesitysurgery with diabetes

One group with obesity and concomitant type 2 diabetes

Procedure: Laparoscopic Roux-en-y gastric bypass

Obesity surgery

Other: Obesitysurgery and non-diabetes

One group with obesity alone

Procedure: Laparoscopic Roux-en-y gastric bypass

Obesity surgery

Outcome Measures

Primary Outcome Measures

Blood tests for endothelial function comparing two years after surgery with baseline (below referred to as "changes in"). [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"). [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"). [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"). [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.)