Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland
Esbjerg, 6700, Denmark
NCT Number: NCT03176615
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Esbjerg, 6700, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 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.
Time frame: 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.
Time frame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Bacterial components of fecal samples
Esbjerg Hospital - University Hospital of Southern Denmark
Other
Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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