Meal-induced Thrombin Generation Before and After Gastric Bypass

Modulex

Status: Completed

Conditions: Weight Loss; Morbid Obesity

Treatments: Dietary Supplement: Experimental diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03176615

HospitalSWJ

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group A (Cross-over Group 1)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Experimental diet

Group B (Cross-over Group 2)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Experimental diet