Meal-induced Thrombin Generation Before and After Gastric Bypass

Sponsor

Hospital of South West Jutland (Other)

Overall Status

Completed

CT.gov ID

NCT03176615

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity Weight Loss	Dietary Supplement: Experimental diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

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)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:

None (Open Label)

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

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

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)

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.]
Blood samples are collected after high-fat and low-fat meals on two study days.
Laboratory tests of fecal samples [Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.]
Bacterial components of fecal samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland	Esbjerg		Denmark	6700

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Line Espenhain Landgrebe, Principal Investigator, Hospital of South West Jutland

ClinicalTrials.gov Identifier:

NCT03176615

Other Study ID Numbers:

HospitalSWJ

First Posted:

Jun 5, 2017

Last Update Posted:

Dec 1, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Line Espenhain Landgrebe, Principal Investigator, Hospital of South West Jutland

Gastric Bypass

Additional relevant MeSH terms:

Obesity, Morbid

Weight Loss

Study Results

No Results Posted as of Dec 1, 2021