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

NCT ID: NCT04859816

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Roux-en-Y gastric bypass operated participants

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

Group Type EXPERIMENTAL

Metabolic test

Intervention Type OTHER

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

DXA-scan

Intervention Type OTHER

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

MRS

Intervention Type OTHER

Magnetic resonance spectroscopy of liver fat content

Feces collection

Intervention Type OTHER

4-day feces collection

Control participants

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

Group Type EXPERIMENTAL

Metabolic test

Intervention Type OTHER

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

DXA-scan

Intervention Type OTHER

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

MRS

Intervention Type OTHER

Magnetic resonance spectroscopy of liver fat content

Feces collection

Intervention Type OTHER

4-day feces collection

Interventions

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Metabolic test

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

Intervention Type OTHER

DXA-scan

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

Intervention Type OTHER

MRS

Magnetic resonance spectroscopy of liver fat content

Intervention Type OTHER

Feces collection

4-day feces collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Morten Gadegaard Hindsø, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FAT-BAR

Identifier Type: -

Identifier Source: org_study_id

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