Meal-induced Thrombin Generation Before and After Gastric Bypass

Weight Loss Clinical Trial

Official title:

Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176615
• Other study ID #: HospitalSWJ
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2021
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

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)

Locations

Country	Name	City	State
Denmark	Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland	Esbjerg

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postprandial peak mean of cardiovascular risk markers 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	Laboratory tests of fecal samples	Bacterial components of fecal samples	Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.