Carbohydrates and Gut Hormones After Gastric Bypass Surgery

Overweight Clinical Trial

Official title:

Effects of Carbohydrates on Gut Hormone Secretion After Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879955
• Other study ID #: CM-CARB-16
• Status: Completed
• Phase: N/A
• First received: August 11, 2016
• Last updated: July 18, 2017
• Start date: August 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Dept. of Endocrinology	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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