Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass

Bariatric Surgery Clinical Trial

— FAT-BAR  

Official title:

Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859816
• Other study ID #: FAT-BAR
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using intravenous and oral administration of stable isotope tracers, we will investigate the importance of altered fat absorption and altered whole body fat metabolism for the reduced postprandial systemic TAG concentrations in non-diabetic patients in weight stable phase after RYGB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria, RYGB

• Age > 18 years
• RYGB > 12 months prior to inclusion
• Weight stable (± 3 kg during the last month)
• HbA1c < 48 mmol/mol before surgery, and no history of diabetes
• HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion Inclusion criteria, CON
• Age > 18 years
• No former bariatric surgery
• Weight stable (± 3 kg during the last month)
• HbA1c < 48 mmol/mol, fasting plasma glucose < 6.1, and no history of diabetes Exclusion criteria
• Thyrotoxicosis or inadequately treated hypothyreosis
• Haemoglobin < 6.5 mmol/l at inclusion
• Pregnancy (pregnancy test in fertile woman before enrolment) or breast feeding
• Medication affecting the planned examinations which cannot be paused during the study period.
• Adherence to extreme diets with excessively high or low contributions from certain macronutrients (e.g. ketogenic diet)
• Complications restricting eating behavior (e.g. postprandial hypoglycemia, vomiting or strictures)
• MR contraindications

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Other:
• Metabolic test
Iv and oral administration of stable isotope tracers during fasting and a high-fat liquid mixed meal
• DXA-scan
Dual energy X-ray Absorptiometry scan of whole-body fat
• MRS
Magnetic resonance spectroscopy of liver fat content
• Feces collection
4-day feces collection

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of plasma triacylglycerol	During a high-fat liquid mixed meal test	6 hours
Secondary	Recovery of oral stable triacylglycerol isotope tracer in feces	An oral stable triacylglycerol isotope tracer will be administered during a high-fat liquid mixed meal test. Feces will be collected the following 4 days to determine the recovery of the tracer in feces.	4 days