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

NCT04859816 | Completed

• 1 other identifier: FAT-BAR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery

Keywords

fat; triglyceride; triacylglycerol; Roux-en-Y gastric bypass; malabsorption

Outcome Measures

Primary Outcomes (1)

• Area under the curve of plasma triacylglycerol

  During a high-fat liquid mixed meal test

  6 hours

Secondary Outcomes (1)

• Recovery of oral stable triacylglycerol isotope tracer in feces

  4 days

Study Arms (2)

Roux-en-Y gastric bypass operated participants

EXPERIMENTAL

Roux-en-Y gastric bypass operated participants in weight stable phase \> 1 year from surgery

Other: Metabolic test; Other: DXA-scan; Other: MRS; Other: Feces collection

Control participants

EXPERIMENTAL

Age, sex, and BMI-matched un-operated participants.

Other: Metabolic test; Other: DXA-scan; Other: MRS; Other: Feces collection

Interventions

Metabolic test OTHER

Iv and oral administration of stable isotope tracers during fasting and a high-fat liquid mixed meal

Control participants; Roux-en-Y gastric bypass operated participants

DXA-scan OTHER

Dual energy X-ray Absorptiometry scan of whole-body fat

Control participants; Roux-en-Y gastric bypass operated participants

MRS OTHER

Magnetic resonance spectroscopy of liver fat content

Control participants; Roux-en-Y gastric bypass operated participants

Feces collection OTHER

4-day feces collection

Control participants; Roux-en-Y gastric bypass operated participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Weight stable (± 3 kg during the last month)
• HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
• 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

You may not qualify if:

• Thyrotoxicosis or inadequately treated hypothyreosis
• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Platelet Glycoprotein IV Deficiency; Malabsorption Syndromes

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 26, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)