Carbohydrates and Gut Hormones After Gastric Bypass Surgery

Effects of Carbohydrates on Gut Hormone Secretion After Gastric Bypass Surgery

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Other: Glucose + Fructose; Other: Sucrose; Other: Isomaltulose; Other: Sucrose + Acarbose

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Dept. of Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: 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.; 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.; 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.; 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.
EXPERIMENTAL: 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.	Other: 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.; 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-240 min following carbohydrate ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-240 min following carbohydrate ingestion
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.	0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of glucose within and between groups.		0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of insulin within and between groups.		0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of C-Peptide within and between groups.		0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of peptide YY (PYY) within and between groups.		0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of Gastric Inhibitory Peptide (GIP) within and between groups.		0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of glucagon within and between groups.		0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of oxyntomodulin within and between groups.		0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of cholecystokinin (CCK) within and between groups.		0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of bile acids within and between groups.		0-240 min following carbohydrate ingestion

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (ESTIMATE): August 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Overweight; Bariatric Surgery; Carbohydrates; Glucagon-Like Peptide 1; Gastric bypass
• Additional Relevant MeSH Terms: Body Weight; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose
• Other Study ID Numbers: CM-CARB-16