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

• Sponsor: Hvidovre University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04859816
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery	Other: Metabolic test; Other: DXA-scan; Other: MRS; Other: Feces collection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass
• Actual Study Start Date: Apr 1, 2021
• Actual Primary Completion Date: May 1, 2022
• Actual Study Completion Date: May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Area under the curve of plasma triacylglycerol [6 hours]

   During a high-fat liquid mixed meal test

Secondary Outcome Measures

1. Recovery of oral stable triacylglycerol isotope tracer in feces [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre Hospital	Hvidovre		Denmark	2650

Sponsors and Collaborators

• Hvidovre University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Morten Gadegaard Hindsø, MD, Principal Investigator, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT04859816
• Other Study ID Numbers: FAT-BAR
• First Posted: Apr 26, 2021
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Morten Gadegaard Hindsø, MD, Principal Investigator, Hvidovre University Hospital: fat; triglyceride; triacylglycerol; Roux-en-Y gastric bypass; malabsorption

Study Results

No Results Posted as of Aug 23, 2022