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Meal-induced Thrombin Generation Before and After Gastric Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03176615
Recruitment Status : Active, not recruiting
First Posted : June 5, 2017
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Line Espenhain Landgrebe, Hospital of South West Jutland

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Weight Loss Dietary Supplement: Experimental diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A (Cross-over Group 1)
Subjects randomly assigned to two experimental diets. This arm will receive high-fat meals first, followed by a washout period of two-seven days and then low-fat meals.
Dietary Supplement: Experimental 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)

Experimental: Group B (Cross-over Group 2)
Subjects randomly assigned to two experimental diets. This arm will receive low-fat meals first, followed by a washout period of two-seven days and then high-fat meals.
Dietary Supplement: Experimental 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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176615


Locations
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Denmark
Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland
Esbjerg, Denmark, 6700
Sponsors and Collaborators
Hospital of South West Jutland
Investigators
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Study Chair: Else Bladbjerg, M.Sc. PhD Unit for Thrombosis Research, Department of Regional Health Research, Hospital of South West Jutland and University of Southern Denmark
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Responsible Party: Line Espenhain Landgrebe, Principal Investigator, Hospital of South West Jutland
ClinicalTrials.gov Identifier: NCT03176615    
Other Study ID Numbers: HospitalSWJ
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Line Espenhain Landgrebe, Hospital of South West Jutland:
Gastric Bypass
Additional relevant MeSH terms:
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Obesity, Morbid
Weight Loss
Body Weight Changes
Body Weight
Obesity
Overnutrition
Nutrition Disorders
Overweight