Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass (FAT-BAR)

August 20, 2022 updated by: Morten Gadegaard Hindsø, MD, Hvidovre University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Roux-en-Y gastric bypass operated participants
Roux-en-Y gastric bypass operated participants in weight stable phase > 1 year from surgery
Other: Metabolic test
Iv and oral administration of stable isotope tracers during fasting and a high-fat liquid mixed meal
Other: DXA-scan
Dual energy X-ray Absorptiometry scan of whole-body fat
Other: MRS
Magnetic resonance spectroscopy of liver fat content
Other: Feces collection
4-day feces collection
Experimental: Control participants
Age, sex, and BMI-matched un-operated participants.
Other: Metabolic test
Iv and oral administration of stable isotope tracers during fasting and a high-fat liquid mixed meal
Other: DXA-scan
Dual energy X-ray Absorptiometry scan of whole-body fat
Other: MRS
Magnetic resonance spectroscopy of liver fat content
Other: Feces collection
4-day feces collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve of plasma triacylglycerol
Time Frame: 6 hours
During a high-fat liquid mixed meal test
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of oral stable triacylglycerol isotope tracer in feces
Time Frame: 4 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 20, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAT-BAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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