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Meal-induced Thrombin Generation Before and After Gastric Bypass

NCT ID: NCT03176615

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity Weight Loss

Keywords

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Gastric Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Experimental diet

Intervention Type 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)

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.

Group Type EXPERIMENTAL

Experimental diet

Intervention Type 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)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Line Espenhain Landgrebe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Else Bladbjerg, M.Sc. PhD

Role: STUDY_CHAIR

Unit for Thrombosis Research, Department of Regional Health Research, Hospital of South West Jutland and University of Southern Denmark

Locations

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

Esbjerg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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HospitalSWJ

Identifier Type: -

Identifier Source: org_study_id