Meal-induced Thrombin Generation Before and After Gastric Bypass


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Verified June 2017 by Line Espenhain Andersen, Hospital of South West Jutland

Sponsor:

Information provided by (Responsible Party):

Line Espenhain Andersen, Hospital of South West Jutland

ClinicalTrials.gov Identifier:

NCT03176615

First received: May 29, 2017

Last updated: June 2, 2017

Last verified: June 2017

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.

Morbid Obesity
Weight Loss
Dietary Supplement: Experimental diet

Study Type: Interventional
Study Design: 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: No masking
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

Primary Outcome Measures:

Secondary Outcome Measures:

  • A panel of blood tests [ Time Frame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery. ]

    Other thrombotic risk markers are measured in blood samples. Secondary blood samples are collected together with the primary blood samples.

  • 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

Estimated Enrollment: 30
Anticipated Study Start Date: June 1, 2017
Estimated Study Completion Date: June 1, 2020
Estimated Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)
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)

Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03176615

Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland
Esbjerg, Denmark, 6700
Contact: Claus Bogh Juhl, MD PhD       claus.bogh.juhl@rsyd.dk   
Principal Investigator: Claus Bogh Juhl, MD PhD’         
Unit for Thrombosis Research, Dep. of Clinical Biochemistry, Hospital of South West Jutland
Esbjerg, Denmark, 6700
Contact: Else Bladbjerg, M.Sc.PhD    +4579182423    Else.Bladbjerg@rsyd.dk   
Principal Investigator: Line Espenhain Andersen, M.Sc.         

Hospital of South West Jutland

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

Responsible Party: Line Espenhain Andersen, Principal Investigator, Hospital of South West Jutland
ClinicalTrials.gov Identifier: NCT03176615     History of Changes
Other Study ID Numbers: HospitalSWJ
Study First Received: May 29, 2017
Last Updated: June 2, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Line Espenhain Andersen, Hospital of South West Jutland:

Gastric Bypass

Additional relevant MeSH terms:

Weight Loss
Obesity, Morbid
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Thrombin
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on June 05, 2017