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

NCT ID: NCT06071559

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2022-06-01

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.

Conditions

Surgery; Obesity Associated Disorder; Coagulation Disorder; Diabetes Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Obesitysurgery with diabetes

One group with obesity and concomitant type 2 diabetes

Group Type: OTHER

Laparoscopic Roux-en-y gastric bypass

Intervention Type: PROCEDURE

Obesity surgery

Obesitysurgery and non-diabetes

One group with obesity alone

Group Type: OTHER

Laparoscopic Roux-en-y gastric bypass

Intervention Type: PROCEDURE

Obesity surgery

Interventions

Laparoscopic Roux-en-y gastric bypass

Obesity surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Ersta Diakoni

OTHER

Sponsor Role: lead

Responsible Party

Anders Thorell

Consultant Surgeon, Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders Thorell, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet Danderyds sjukhus/Ersta sjukhus

Other Identifiers

2014/1793-31/1

Identifier Type: -

Identifier Source: org_study_id