Carbohydrates and Gut Hormones After Gastric Bypass Surgery

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Other: Glucose + Fructose; Other: Sucrose; Other: Isomaltulose; Other: Sucrose + Acarbose

• Registration Number: NCT02879955
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-26
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10 gastric bypass operated patients	Isomaltulose	4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
10 healthy control subjects	Glucose + Fructose	4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
10 healthy control subjects	Isomaltulose	4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
10 healthy control subjects	Sucrose + Acarbose	4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
10 gastric bypass operated patients	Glucose + Fructose	4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
10 gastric bypass operated patients	Sucrose	4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
10 gastric bypass operated patients	Sucrose + Acarbose	4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
10 healthy control subjects	Sucrose	4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.

Primary Outcome Measures

Name	Time	Method
Within group difference in GLP-1 secretion (evaluated by iAUC).	0-240 min following carbohydrate ingestion	Comparison of the GLP-1 responses (evaluated by iAUC) induced by the different carbohydrate loads.

Secondary Outcome Measures

Name	Time	Method
Responses (evaluated by iAUC) of Gastric Inhibitory Peptide (GIP) 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
Between group comparison of GLP-1 secretion (evaluated by iAUC).	0-240 min following carbohydrate ingestion	GLP-1 secretion (evaluated by iAUC) in gastric bypass operated patients compared to BMI-matched control subjects for each of the carbohydrate loads.
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 glucose 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 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
Between group comparison of differences in GLP-1 secretion (evaluated by iAUC).	0-240 min following carbohydrate ingestion	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 bile acids within and between groups.	0-240 min following carbohydrate ingestion

Trial Locations

Locations (1)

Dept. of Endocrinology; 🇩🇰 Hvidovre, Denmark