Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery

NCT ID: NCT04082923

Last Updated: 2021-09-01

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-03

Study Completion Date

2021-05-01

Brief Summary

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The investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery.

Detailed Description

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Conditions

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Glucose Metabolism Disorders Obesity Sleeve Gastrectomy Gastric Bypass Gut Hormones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Gastric bypass operated patients

Two test days in a randomized, patient-blinded, cross-over design

Group Type OTHER

Liquid meal

Intervention Type OTHER

Four-hour liquid mixed meal test

Solid meal

Intervention Type OTHER

Four-hour solid mixed meal test

Gastric sleeve operated patients

Two test days in a randomized, patient-blinded, cross-over design

Group Type OTHER

Liquid meal

Intervention Type OTHER

Four-hour liquid mixed meal test

Solid meal

Intervention Type OTHER

Four-hour solid mixed meal test

Control arm

Two test days in a randomized, patient-blinded, cross-over design

Group Type OTHER

Liquid meal

Intervention Type OTHER

Four-hour liquid mixed meal test

Solid meal

Intervention Type OTHER

Four-hour solid mixed meal test

Interventions

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Liquid meal

Four-hour liquid mixed meal test

Intervention Type OTHER

Solid meal

Four-hour solid mixed meal test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* RYGB or SG operation \> 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

Exclusion Criteria

* Thyrotoxicosis or inadequately treated hypothyreosis
* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations
Minimum Eligible Age

18 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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Nora Elisabeth Hedbäck

MD, principal inverstigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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NOra Hedbäck, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology Hvidovre Hospital Denmark

Locations

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Department of Endocrinology, Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Countries

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Denmark

References

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Hedback N, Hindso M, Bojsen-Moller KN, Linddal AK, Jorgensen NB, Dirksen C, Moller A, Kristiansen VB, Hartmann B, Holst JJ, Svane MS, Madsbad S. Effect of Meal Texture on Postprandial Glucose Excursions and Gut Hormones After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Front Nutr. 2022 Apr 29;9:889710. doi: 10.3389/fnut.2022.889710. eCollection 2022.

Reference Type DERIVED
PMID: 35571890 (View on PubMed)

Other Identifiers

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H-19027100

Identifier Type: -

Identifier Source: org_study_id

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