Clinical trial NCT06071559: Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.
Official title: Effects of Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Obesity Associated Disorder
Coagulation Disorder
Diabetes Complications
Keywords: Bariatric surgery
Fibrinolysis
Lead sponsor: Ersta Diakoni
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2023-10-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Blood tests for endothelial function comparing two years after surgery with baseline (below referred to as "changes in").
timeFrame: before surgery - 2 years after surgery
measure: Blood tests for fibrinolysis comparing two years after surgery with baseline (below referred to as "changes in").
timeFrame: before surgery - 2 years after surgery
measure: Blood tests for inflammation comparing two years after surgery with baseline (below referred to as "changes in").
timeFrame: before surgery - 2 years after surgery
measure: Blood tests for extracellular vesicles comparing two years after surgery with baseline (below referred to as "changes in").
timeFrame: before surgery - 2 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet Danderyds sjukhus/Ersta sjukhus
name: Anders Thorell, Professor
role: PRINCIPAL_INVESTIGATOR
References: