Clinical trial NCT03176615: Meal-induced Thrombin Generation Before and After Gastric Bypass
Official title: Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Weight Loss
Keywords: Gastric Bypass
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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)
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postprandial peak mean of prothrombin fragment 1+2 concentrations
timeFrame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Secondary outcomes:
measure: Postprandial peak mean of cardiovascular risk markers concentrations
timeFrame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
measure: Laboratory tests of fecal samples
timeFrame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland
Study officials:
affiliation: Unit for Thrombosis Research, Department of Regional Health Research, Hospital of South West Jutland and University of Southern Denmark
name: Else Bladbjerg, M.Sc. PhD
role: STUDY_CHAIR
References: