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Meal-induced Thrombin Generation Before and After Gastric Bypass

NCT03176615 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-12-01

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2021-02-01
Completion
2021-11-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176615 on ClinicalTrials.gov