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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obesitysurgery with diabetes | Other | One group with obesity and concomitant type 2 diabetes |
|
| Obesitysurgery and non-diabetes | Other | One group with obesity alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Roux-en-y gastric bypass | Procedure | Obesity surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood tests for endothelial function comparing two years after surgery with baseline (below referred to as "changes in"). | Outcome measure:
| 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:
| 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:
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Thorell, Professor | Karolinska Institutet Danderyds sjukhus/Ersta sjukhus | Principal Investigator |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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