Carbohydrates and Gut Hormones After Gastric Bypass Surgery

NCT ID: NCT02879955

Last Updated: 2017-07-19

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-06-30

Brief Summary

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To investigate the secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1), after ingestion of glucose and fructose as separate monosaccharides or combined in the disaccharides sucrose and isomaltulose and the effect of acarbose in gastric bypass operated subjects and BMI-matched controls.

Detailed Description

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Disaccharides such as sucrose or isomaltulose (also called palatinose) require digestion into monosaccharides (both are digested to glucose and fructose) by enzymes located in the brush border of the small intestine to be absorbed. The study will investigate the influence of carbohydrate digestion on gut hormone secretion.

Conditions

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Overweight

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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10 gastric bypass operated patients

4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.

Group Type EXPERIMENTAL

Glucose + Fructose

Intervention Type OTHER

Ingestion of the separate monosaccharides glucose (25 g) and fructose (25 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Sucrose

Intervention Type OTHER

Ingestion of the disaccharide sucrose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Isomaltulose

Intervention Type OTHER

Ingestion of the slowly digestable disaccharide isomaltulose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Sucrose + Acarbose

Intervention Type OTHER

Ingestion of the disaccharide sucrose (47.5 g) and the alpha glucosidase inhibitor acarbose dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

10 healthy control subjects

4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.

Group Type EXPERIMENTAL

Glucose + Fructose

Intervention Type OTHER

Ingestion of the separate monosaccharides glucose (25 g) and fructose (25 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Sucrose

Intervention Type OTHER

Ingestion of the disaccharide sucrose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Isomaltulose

Intervention Type OTHER

Ingestion of the slowly digestable disaccharide isomaltulose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Sucrose + Acarbose

Intervention Type OTHER

Ingestion of the disaccharide sucrose (47.5 g) and the alpha glucosidase inhibitor acarbose dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Interventions

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Glucose + Fructose

Ingestion of the separate monosaccharides glucose (25 g) and fructose (25 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Intervention Type OTHER

Sucrose

Ingestion of the disaccharide sucrose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Intervention Type OTHER

Isomaltulose

Ingestion of the slowly digestable disaccharide isomaltulose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Intervention Type OTHER

Sucrose + Acarbose

Ingestion of the disaccharide sucrose (47.5 g) and the alpha glucosidase inhibitor acarbose dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion Criteria

* Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM

Healthy control subjects:


* Bariatric surgery or complicated upper abdominal surgery
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM
* Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christoffer Martinussen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Endocrinology

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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Martinussen C, Bojsen-Moller KN, Dirksen C, Svane MS, Kristiansen VB, Hartmann B, Holst JJ, Madsbad S. Augmented GLP-1 Secretion as Seen After Gastric Bypass May Be Obtained by Delaying Carbohydrate Digestion. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3233-3244. doi: 10.1210/jc.2018-02661.

Reference Type DERIVED
PMID: 30844053 (View on PubMed)

Other Identifiers

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CM-CARB-16

Identifier Type: -

Identifier Source: org_study_id

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