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Completed

NCT Number: NCT03176615

Meal-induced Thrombin Generation Before and After Gastric Bypass

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland

Esbjerg, 6700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental diet

Dietary Supplement

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)

Primary outcomes

  1. Postprandial peak mean of prothrombin fragment 1+2 concentrations

    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.

Secondary outcomes

  1. Postprandial peak mean of cardiovascular risk markers concentrations

    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.

  2. Laboratory tests of fecal samples

    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

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Official study title

Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2017
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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