Meal-induced Thrombin Generation Before and After Gastric Bypass

NCT03176615 | Completed DMC

• 1 other identifier: HospitalSWJ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Weight Loss

Keywords

Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postprandial peak mean of cardiovascular risk markers concentrations

  Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.

• Laboratory tests of fecal samples

  Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.

Study Arms (2)

Group A (Cross-over Group 1)

EXPERIMENTAL

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

Group B (Cross-over Group 2)

EXPERIMENTAL

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

Interventions

Experimental diet 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 A (Cross-over Group 1); Group B (Cross-over Group 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible for gastric bypass surgery

You may not qualify if:

• Use of anticoagulants, platelet inhibitors and oral contraceptives
• Known liver diseases, any malignant disorders, or known coagulation diseases

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

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

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 5, 2017
• Study Start: September 1, 2017
• Primary Completion: February 1, 2021
• Study Completion: November 30, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)