OverweightNCT02879955
Carbohydrates and Gut Hormones After Gastric Bypass Surgery
A study testing Glucose + Fructose, Sucrose and Isomaltulose in people with Overweight, run by Hvidovre University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Glucose + Fructose, Sucrose and Isomaltulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- uncomplicated gastric bypass surgery performed minimum 12 months prior to study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Glucose + Fructose, Sucrose, Isomaltulose, Sucrose + Acarbose
- Keywords
- Glucagon-Like Peptide 1, Carbohydrates, Gastric bypass, Bariatric Surgery, Overweight
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose + FructoseOther
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.
SucroseOther
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.
IsomaltuloseOther
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 + AcarboseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 gastric bypass operated patients | Experimental | 4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion. Receives: Other: Glucose + Fructose; Other: Sucrose; Other: Isomaltulose; Other: Sucrose + Acarbose |
| 10 healthy control subjects | Experimental | 4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion. Receives: Other: Glucose + Fructose; Other: Sucrose; Other: Isomaltulose; Other: Sucrose + Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-240 min following carbohydrate ingestion
Secondary outcomes (11)
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.
Measured: 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.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of glucose within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of insulin within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of C-Peptide within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of peptide YY (PYY) within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of Gastric Inhibitory Peptide (GIP) within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of glucagon within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of oxyntomodulin within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of cholecystokinin (CCK) within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of bile acids within and between groups.
Measured: 0-240 min following carbohydrate ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Christoffer Martinussen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879955
- Sponsor's protocol ID
- CM-CARB-16
- Status last verified
- Jul 2017
- First submitted
- 11 Aug 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30844053
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carbohydrates on Gut Hormone Secretion After Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02879955
- Acronym / sponsor ID
- CM-CARB-16
- Conditions
- Overweight
- Keywords
- Glucagon-Like Peptide 1, Carbohydrates, Gastric bypass, Bariatric Surgery, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 gastric bypass operated patients | Experimental | Other: Glucose + Fructose, Other: Sucrose, Other: Isomaltulose, Other: Sucrose + Acarbose4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion. |
| 10 healthy control subjects | Experimental | Other: Glucose + Fructose, Other: Sucrose, Other: Isomaltulose, Other: Sucrose + Acarbose4 different carbohydrate loads ingested at separate study days will be tested against each others ability to induce GLP-1 secretion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- uncomplicated gastric bypass surgery performed minimum 12 months prior to study
Key exclusion criteria (8 listed)
- Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
- Pregnancy or breastfeeding
- Haemoglobin levels below 6,5 mM
- Bariatric surgery or complicated upper abdominal surgery
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose + FructoseIngestion 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 | 10 gastric bypass operated patients, 10 healthy control subjects |
| SucroseIngestion 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 | 10 gastric bypass operated patients, 10 healthy control subjects |
| IsomaltuloseIngestion 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 | 10 gastric bypass operated patients, 10 healthy control subjects |
| Sucrose + AcarboseIngestion 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. | Other | 10 gastric bypass operated patients, 10 healthy control subjects |
Primary outcome
Within group difference in GLP-1 secretion (evaluated by iAUC).
Time frame: 0-240 min following carbohydrate ingestion
Comparison of the GLP-1 responses (evaluated by iAUC) induced by the different carbohydrate loads.
11 secondary outcomes
Between group comparison of GLP-1 secretion (evaluated by iAUC).
Time frame: 0-240 min following carbohydrate ingestion
Between group comparison of differences in GLP-1 secretion (evaluated by iAUC).
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of glucose within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of insulin within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of C-Peptide within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of peptide YY (PYY) within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of Gastric Inhibitory Peptide (GIP) within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of glucagon within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of oxyntomodulin within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of cholecystokinin (CCK) within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Responses (evaluated by iAUC) of bile acids within and between groups.
Time frame: 0-240 min following carbohydrate ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Derived from this study: PubMed 30844053Martinussen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose + Fructose, Sucrose and Isomaltulose in people with Overweight, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within group difference in GLP-1 secretion (evaluated by iAUC). (time frame: 0-240 min following carbohydrate ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.