Morbid Obesity, Weight Loss
Conditions
Keywords
Gastric Bypass
Brief summary
The purpose of this study is to investigate harmful effects of intentional weight loss. Intentional weight loss has been linked to increased risk of cardiovascular disease in overweight individuals, but the link between intentional weight loss and thrombotic disease is poorly understood. Postprandial coagulation activation, including thrombin generation, is a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass will be included in a randomized, cross-over clinical trial. All patients will consume a high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven days apart). This cross-over study will be carried out before weight loss, during lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass. Fasting and postprandial blood samples are collected on each study days, while one fecal sample is collected for each study period. The study will contribute to our understanding of mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in relation to intentional weight loss programs must be modified.
Interventions
DIETARY_SUPPLEMENTExperimental diet
The intervention will run concurrently with the gastric bypass treatment at the hospital. The first intervention is carried out before weight loss, and the intervention is repeated two times concurrently with two periods of weight loss (lifestyle and gastric bypass)
Sponsors
Esbjerg Hospital - University Hospital of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will consume a high-fat meal and a low-fat meal served seperately in a randomized order on two seperate days (two-seven days apart)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Eligible for gastric bypass surgery
Exclusion criteria
* Use of anticoagulants, platelet inhibitors and oral contraceptives * Known liver diseases, any malignant disorders, or known coagulation diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial peak mean of prothrombin fragment 1+2 concentrations | Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery. | Blood samples are collected after high-fat and low-fat meals on two study days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial peak mean of cardiovascular risk markers concentrations | Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery. | Blood samples are collected after high-fat and low-fat meals on two study days. |
| Laboratory tests of fecal samples | Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery. | Bacterial components of fecal samples |
Countries
Denmark
Outcome results
None listed