ObesityGLUBYPASSNCT02789553
Starches Digestion After Obesity Surgery.
A study testing First starch meal then meal with glucose syrup and First meal with glucose syrup then starch meal in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has been associated with the onset of hyperglycemic peaks, which are very intensive and transient, in formally non diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- First starch meal then meal with glucose syrup and First meal with glucose syrup then starch meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2018to 2 Jul 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Obese patients before obesity-surgery (HAS 2009 criteria for obesity-surgery)
- Patients accepted for a gastric bypass
- Patient consent the principle of 2 evaluations (one before surgery and another 3 months after surgery)
- Patient that give their informed consent before any procedure for the study
- Patient affiliated with a health insurance scheme
Who cannot join
- Diabetes (whatever the treatment), post-surgery diarrhea, small intestine disease
- Known microbial outbreak
- Anti-thrombin therapy
- Treatment which can modify the intestinal transit (anti-diarrhea, thyroid hormones…)
- Pregnant woman or breastfeeding.
- Patient not available for the two evaluations
- Protected adults (guardianship by court order)
- Patients participating to another treatment research protocol during the time of this study
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Endocrinology, metabolic diseases and nutrition
Toulouse, 31059
About this study
Official title: Starches Digestion After Obesity Surgery. A Comparative Study.
Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has been associated with the onset of hyperglycemic peaks, which are very intensive and transient, in formally non diabetic patients. The aim of this study is to study the digestion of starch as compared to that of glucose (same glucose load) before and after gastric bypass surgery in obese patients.
Volunteers will be recruited among the candidates to a gastric bypass, and will be studied before and 3 months after surgery. They will have on each occasion 2 random meals, corresponding to 30g glucose, one made of starch the other made of glucose, both naturally labeled with 13C. The digestion of starch will be assessed with the increase in the plasma 13C-glucose tracer. Plasma samples will be collected for 3 hours.
Some studies have already investigated time of absorption of glucose, but any study has examined the time of digestion of glucose. Other study always used glucose syrup, so they cannot have results about digestion. It is the reason why, in this study, glucose syrup and a starch meal will be taken by the same patient and glycaemia will be compared. In this way, results will be obtained about the kinetic of digestion of starch.
Read the detailed description
Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has been associated with the onset of hyperglycemic peaks, which are very intensive and transient, in formally non diabetic patients. The aim of this study is to study the digestion of starch as compared to that of glucose (same glucose load) before and after gastric bypass surgery in obese patients.
Volunteers will be recruited among the candidates to a gastric bypass, and will be studied before and 3 months after surgery. They will have on each occasion 2 random meals, corresponding to 30g glucose, one made of starch the other made of glucose, both naturally labeled with 13C. The digestion of starch will be assessed with the increase in the plasma 13C-glucose tracer. Plasma samples will be collected for 3 hours.
Some studies have already investigated time of absorption of glucose, but any study has examined the time of digestion of glucose. Other study always used glucose syrup, so they cannot have results about digestion. It is the reason why, in this study, glucose syrup and a starch meal will be taken by the same patient and glycaemia will be compared. In this way, results will be obtained about the kinetic of digestion of starch.
All patients will have two evaluations: one before the bypass surgery and one 3 months after. All evaluation will include 2 standard meals. Patients have to be fasted, and they will take in a randomized order the same glucose quantity: 30g, for the breakfast. After each meal, blood sample will be collected during 3 hours at time 0, 10, 20, 30, 40, 50, 60 minutes and every 30 minutes until time 180.
The starch meal will provide 30g of glucose in the form of corn starch. It will be consumed in 15 minutes. They are any other food in the meal. This quantity is corresponding to what patients can ingest after a bypass surgery, because of the poor size of their stomach. C13-carbon is a natural tracer into the corn. The measure of the increase of C13-glucose in the plasma is showing the appearance of the tracer, corresponding to the starch digestion.
The second meal is composed by 30g of corn glucose (glucose-meal), in liquid form and will be dived in 3 portions to be ingested in 15 minutes, like the starch meal. They are any other food in the meal.
- Conditions
- Obesity
- Being tested
- First starch meal then meal with glucose syrup, First meal with glucose syrup then starch meal
- Keywords
- Glucose digestion, Bypass surgery, C13-glucose tracer, Insulin secretion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First starch meal then meal with glucose syrupOther
Before bypass surgery, patients will take randomized meal. One day a starch meal and another day a glucose syrup meal. 3 months after surgery, they will take these 2 randomized meal again, one day the first one, and the day after the other one.
First meal with glucose syrup then starch mealOther
Before bypass surgery, patients will take randomized meal. One day a meal with glucose syrup and another day a starch meal. 3 months after surgery, they will take these 2 randomized meal again, one day the first one, and the day after the other one.
| Study group | Role | What they receive |
|---|---|---|
| Meal with glucose syrup | Experimental | Meal with glucose syrup : 30g of glucose mixed with 150 mL of water and dived into three 50 mL portions. It will be consumed in 15 minutes Receives: Other: First starch meal then meal with glucose syrup; Other: First meal with glucose syrup then starch meal |
| Starch meal | Experimental | Starch meal with 30g mixed in 120 mL of water. It will be consumed in 15 minutes and it represents 30g of glucose Receives: Other: First starch meal then meal with glucose syrup; Other: First meal with glucose syrup then starch meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C13 glucose marker appearance: starch diet.
Appearance of the C13-glucose tracer in the plasma, since the beginning of the diet with the starch diet.
Measured: Change from baseline C13 glucose marker appearance at 3 months after surgery
Secondary outcomes (2)
C13 glucose marker appearance: glucose diet.
Appearance of the C13-glucose tracer in the plasma, since the beginning of the diet with the glucose diet.
Measured: Change from baseline C13 glucose marker appearance at 3 months after surgery
Insulin secretion
Insulin secretion will be measured with a deconvolution model.
Measured: Change from baseline insulin secretion at 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start19 Feb 2018
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick RITZ, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789553
- Sponsor's protocol ID
- 13 196 02
- Other IDs
- 2015-A01346-43
- Acronym
- GLUBYPASS
- Status last verified
- Oct 2021
- First submitted
- 24 Mar 2016
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starches Digestion After Obesity Surgery. A Comparative Study.
- ClinicalTrials.gov ID
- NCT02789553
- Acronym / sponsor ID
- GLUBYPASS / 13 196 02
- Conditions
- Obesity
- Keywords
- Glucose digestion, Bypass surgery, C13-glucose tracer, Insulin secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 3 Jun 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.
Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has been associated with the onset of hyperglycemic peaks, which are very intensive and transient, in formally non diabetic patients. The aim of this study is to study the digestion of starch as compared to that of glucose (same glucose load) before and after gastric bypass surgery in obese patients.
Volunteers will be recruited among the candidates to a gastric bypass, and will be studied before and 3 months after surgery. They will have on each occasion 2 random meals, corresponding to 30g glucose, one made of starch the other made of glucose, both naturally labeled with 13C. The digestion of starch will be assessed with the increase in the plasma 13C-glucose tracer. Plasma samples will be collected for 3 hours.
Some studies have already investigated time of absorption of glucose, but any study has examined the time of digestion of glucose. Other study always used glucose syrup, so they cannot have results about digestion. It is the reason why, in this study, glucose syrup and a starch meal will be taken by the same patient and glycaemia will be compared. In this way, results will be obtained about the kinetic of digestion of starch.
Detailed description
Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has been associated with the onset of hyperglycemic peaks, which are very intensive and transient, in formally non diabetic patients. The aim of this study is to study the digestion of starch as compared to that of glucose (same glucose load) before and after gastric bypass surgery in obese patients.
Volunteers will be recruited among the candidates to a gastric bypass, and will be studied before and 3 months after surgery. They will have on each occasion 2 random meals, corresponding to 30g glucose, one made of starch the other made of glucose, both naturally labeled with 13C. The digestion of starch will be assessed with the increase in the plasma 13C-glucose tracer. Plasma samples will be collected for 3 hours.
Some studies have already investigated time of absorption of glucose, but any study has examined the time of digestion of glucose. Other study always used glucose syrup, so they cannot have results about digestion. It is the reason why, in this study, glucose syrup and a starch meal will be taken by the same patient and glycaemia will be compared. In this way, results will be obtained about the kinetic of digestion of starch.
All patients will have two evaluations: one before the bypass surgery and one 3 months after. All evaluation will include 2 standard meals. Patients have to be fasted, and they will take in a randomized order the same glucose quantity: 30g, for the breakfast. After each meal, blood sample will be collected during 3 hours at time 0, 10, 20, 30, 40, 50, 60 minutes and every 30 minutes until time 180.
The starch meal will provide 30g of glucose in the form of corn starch. It will be consumed in 15 minutes. They are any other food in the meal. This quantity is corresponding to what patients can ingest after a bypass surgery, because of the poor size of their stomach. C13-carbon is a natural tracer into the corn. The measure of the increase of C13-glucose in the plasma is showing the appearance of the tracer, corresponding to the starch digestion.
The second meal is composed by 30g of corn glucose (glucose-meal), in liquid form and will be dived in 3 portions to be ingested in 15 minutes, like the starch meal. They are any other food in the meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal with glucose syrup | Experimental | Other: First starch meal then meal with glucose syrup, Other: First meal with glucose syrup then starch mealMeal with glucose syrup : 30g of glucose mixed with 150 mL of water and dived into three 50 mL portions. It will be consumed in 15 minutes |
| Starch meal | Experimental | Other: First starch meal then meal with glucose syrup, Other: First meal with glucose syrup then starch mealStarch meal with 30g mixed in 120 mL of water. It will be consumed in 15 minutes and it represents 30g of glucose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Obese patients before obesity-surgery (HAS 2009 criteria for obesity-surgery)
- Patients accepted for a gastric bypass
- Patient consent the principle of 2 evaluations (one before surgery and another 3 months after surgery)
- Patient that give their informed consent before any procedure for the study
- Patient affiliated with a health insurance scheme
Key exclusion criteria (8 listed)
- Diabetes (whatever the treatment), post-surgery diarrhea, small intestine disease
- Known microbial outbreak
- Anti-thrombin therapy
- Treatment which can modify the intestinal transit (anti-diarrhea, thyroid hormones…)
- Pregnant woman 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 |
|---|---|---|
| First starch meal then meal with glucose syrupBefore bypass surgery, patients will take randomized meal. One day a starch meal and another day a glucose syrup meal. 3 months after surgery, they will take these 2 randomized meal again, one day the first one, and the day after the other one. | Other | Meal with glucose syrup, Starch meal |
| First meal with glucose syrup then starch mealBefore bypass surgery, patients will take randomized meal. One day a meal with glucose syrup and another day a starch meal. 3 months after surgery, they will take these 2 randomized meal again, one day the first one, and the day after the other one. | Other | Meal with glucose syrup, Starch meal |
Primary outcome
Change in C13 glucose marker appearance: starch diet.
Time frame: Change from baseline C13 glucose marker appearance at 3 months after surgery
Appearance of the C13-glucose tracer in the plasma, since the beginning of the diet with the starch diet.
2 secondary outcomes
C13 glucose marker appearance: glucose diet.
Time frame: Change from baseline C13 glucose marker appearance at 3 months after surgery
Insulin secretion
Time frame: Change from baseline insulin secretion at 3 months after surgery
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 4 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Patrick RITZ, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First starch meal then meal with glucose syrup and First meal with glucose syrup then starch meal in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
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 5 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 4 Nov 2021. 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 France. 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?
Change in C13 glucose marker appearance: starch diet. (time frame: Change from baseline C13 glucose marker appearance at 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2021.