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Completed

NCT Number: NCT04859816

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

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.

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Key information

Conditions

Bariatric Surgery Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Platelet Glycoprotein IV Deficiency

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metabolic test

Other

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

DXA-scan

Other

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

MRS

Other

Magnetic resonance spectroscopy of liver fat content

Feces collection

Other

4-day feces collection

Primary outcomes

  1. Area under the curve of plasma triacylglycerol

    Time frame: 6 hours

    During a high-fat liquid mixed meal test

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Acronym: FAT-BAR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2021
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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