Clinical trial NCT02879955: Carbohydrates and Gut Hormones After Gastric Bypass Surgery
Official title: Effects of Carbohydrates on Gut Hormone Secretion After Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Glucagon-Like Peptide 1
Carbohydrates
Gastric bypass
Bariatric Surgery
Overweight
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2016-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Within group difference in GLP-1 secretion (evaluated by iAUC).
timeFrame: 0-240 min following carbohydrate ingestion
Secondary outcomes:
measure: Between group comparison of GLP-1 secretion (evaluated by iAUC).
timeFrame: 0-240 min following carbohydrate ingestion
measure: Between group comparison of differences in GLP-1 secretion (evaluated by iAUC).
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of glucose within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of insulin within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of C-Peptide within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of peptide YY (PYY) within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of Gastric Inhibitory Peptide (GIP) within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of glucagon within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of oxyntomodulin within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of cholecystokinin (CCK) within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
measure: Responses (evaluated by iAUC) of bile acids within and between groups.
timeFrame: 0-240 min following carbohydrate ingestion
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Endocrinology
Study officials:
References:
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.