Meal-induced Thrombin Generation Before and After Gastric Bypass

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Morbid Obesity
• Intervention / Treatment: Dietary supplement: Experimental diet

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial peak mean of prothrombin fragment 1+2 concentrations	Blood samples are collected after high-fat and low-fat meals on two study days.	Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial peak mean of cardiovascular risk markers concentrations	Blood samples are collected after high-fat and low-fat meals on two study days.	Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Laboratory tests of fecal samples	Bacterial components of fecal samples	Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.

Collaborators and Investigators

• Sponsor: Hospital of South West Jutland
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Gastric Bypass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid
• Other Study ID Numbers: HospitalSWJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No