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Carbohydrates and Gut Hormones After Gastric Bypass Surgery

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Glucose + Fructose
Sucrose
Isomaltulose
Sucrose + Acarbose
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring Glucagon-Like Peptide 1, Carbohydrates, Gastric bypass, Bariatric Surgery, Overweight

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Gastric bypass operated patients:

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:

Exclusion Criteria:

  • 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

Sites / Locations

  • Dept. of Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

10 gastric bypass operated patients

10 healthy control subjects

Arm Description

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

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

Outcomes

Primary Outcome Measures

Within group difference in GLP-1 secretion (evaluated by iAUC).
Comparison of the GLP-1 responses (evaluated by iAUC) induced by the different carbohydrate loads.

Secondary Outcome Measures

Between group comparison of GLP-1 secretion (evaluated by iAUC).
GLP-1 secretion (evaluated by iAUC) in gastric bypass operated patients compared to BMI-matched control subjects for each of the carbohydrate loads.
Between group comparison of differences in GLP-1 secretion (evaluated by iAUC).
Differences in GLP-1 secretion (evaluated by iAUC) induced by the different carbohydrate loads in gastric bypass operated patients compared to differences in BMI-matched control subjects.
Responses (evaluated by iAUC) of glucose within and between groups.
Responses (evaluated by iAUC) of insulin within and between groups.
Responses (evaluated by iAUC) of C-Peptide within and between groups.
Responses (evaluated by iAUC) of peptide YY (PYY) within and between groups.
Responses (evaluated by iAUC) of Gastric Inhibitory Peptide (GIP) within and between groups.
Responses (evaluated by iAUC) of glucagon within and between groups.
Responses (evaluated by iAUC) of oxyntomodulin within and between groups.
Responses (evaluated by iAUC) of cholecystokinin (CCK) within and between groups.
Responses (evaluated by iAUC) of bile acids within and between groups.

Full Information

First Posted
August 11, 2016
Last Updated
July 18, 2017
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02879955
Brief Title
Carbohydrates and Gut Hormones After Gastric Bypass Surgery
Official Title
Effects of Carbohydrates on Gut Hormone Secretion After Gastric Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Glucagon-Like Peptide 1, Carbohydrates, Gastric bypass, Bariatric Surgery, Overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 gastric bypass operated patients
Arm Type
Experimental
Arm Description
4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
Arm Title
10 healthy control subjects
Arm Type
Experimental
Arm Description
4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
Intervention Type
Other
Intervention Name(s)
Glucose + Fructose
Intervention Description
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
Intervention Name(s)
Sucrose
Intervention Description
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
Intervention Name(s)
Isomaltulose
Intervention Description
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
Intervention Name(s)
Sucrose + Acarbose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Within group difference in GLP-1 secretion (evaluated by iAUC).
Description
Comparison of the GLP-1 responses (evaluated by iAUC) induced by the different carbohydrate loads.
Time Frame
0-240 min following carbohydrate ingestion
Secondary Outcome Measure Information:
Title
Between group comparison of GLP-1 secretion (evaluated by iAUC).
Description
GLP-1 secretion (evaluated by iAUC) in gastric bypass operated patients compared to BMI-matched control subjects for each of the carbohydrate loads.
Time Frame
0-240 min following carbohydrate ingestion
Title
Between group comparison of differences in GLP-1 secretion (evaluated by iAUC).
Description
Differences in GLP-1 secretion (evaluated by iAUC) induced by the different carbohydrate loads in gastric bypass operated patients compared to differences in BMI-matched control subjects.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of glucose within and between groups.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of insulin within and between groups.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of C-Peptide within and between groups.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of peptide YY (PYY) within and between groups.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of Gastric Inhibitory Peptide (GIP) within and between groups.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of glucagon within and between groups.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of oxyntomodulin within and between groups.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of cholecystokinin (CCK) within and between groups.
Time Frame
0-240 min following carbohydrate ingestion
Title
Responses (evaluated by iAUC) of bile acids within and between groups.
Time Frame
0-240 min following carbohydrate ingestion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Gastric bypass operated patients: 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: Exclusion Criteria: 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
Facility Information:
Facility Name
Dept. of Endocrinology
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30844053
Citation
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.
Results Reference
derived

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Carbohydrates and Gut Hormones After Gastric Bypass Surgery

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