Carbohydrates and Gut Hormones After Gastric Bypass Surgery
Effects of Carbohydrates on Gut Hormone Secretion After Gastric Bypass Surgery
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
August 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 19, 2017
July 1, 2017
10 months
August 11, 2016
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Between group comparison of GLP-1 secretion (evaluated by iAUC).
0-240 min following carbohydrate ingestion
Between group comparison of differences in GLP-1 secretion (evaluated by iAUC).
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
- +6 more secondary outcomes
Study Arms (2)
10 gastric bypass operated patients
EXPERIMENTAL4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
10 healthy control subjects
EXPERIMENTAL4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- uncomplicated gastric bypass surgery performed minimum 12 months prior to study
You may not qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- University of Copenhagencollaborator
Study Sites (1)
Dept. of Endocrinology
Hvidovre, 2650, Denmark
Related Publications (1)
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.
PMID: 30844053DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 11, 2016
First Posted
August 26, 2016
Study Start
August 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
July 19, 2017
Record last verified: 2017-07