Back to resultsMeal-induced Thrombin Generation Before and After Gastric Bypass
Primary Purpose
Morbid Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Experimental diet
Sponsored by
About this trial
This is an interventional prevention trial for Morbid Obesity focused on measuring Gastric Bypass
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
Sites / Locations
- Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A (Cross-over Group 1)
Group B (Cross-over Group 2)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Postprandial peak mean of prothrombin fragment 1+2 concentrations
Blood samples are collected after high-fat and low-fat meals on two study days.
Secondary Outcome Measures
Postprandial peak mean of cardiovascular risk markers concentrations
Blood samples are collected after high-fat and low-fat meals on two study days.
Laboratory tests of fecal samples
Bacterial components of fecal samples
Full Information
NCT ID
NCT03176615
First Posted
May 29, 2017
Last Updated
November 30, 2021
Sponsor
Hospital of South West Jutland
1. Study Identification
Unique Protocol Identification Number
NCT03176615
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital of South West Jutland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Weight Loss
Keywords
Gastric Bypass
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Cross-over Group 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (Cross-over Group 2)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental diet
Intervention Description
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 Measure Information:
Title
Postprandial peak mean of prothrombin fragment 1+2 concentrations
Description
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.
Secondary Outcome Measure Information:
Title
Postprandial peak mean of cardiovascular risk markers concentrations
Description
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.
Title
Laboratory tests of fecal samples
Description
Bacterial components of fecal samples
Time Frame
Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Else Bladbjerg, M.Sc. PhD
Organizational Affiliation
Unit for Thrombosis Research, Department of Regional Health Research, Hospital of South West Jutland and University of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Meal-induced Thrombin Generation Before and After Gastric Bypass
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