Starches Digestion After Obesity Surgery. (GLUBYPASS)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
First starch meal then meal with glucose syrup
First meal with glucose syrup then starch meal
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring Glucose digestion, Bypass surgery, C13-glucose tracer, Insulin secretion
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Department of Endocrinology, metabolic diseases and nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Meal with glucose syrup
Starch meal
Arm Description
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
Starch meal with 30g mixed in 120 mL of water. It will be consumed in 15 minutes and it represents 30g of glucose
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Insulin secretion
Insulin secretion will be measured with a deconvolution model.
Full Information
NCT ID
NCT02789553
First Posted
March 24, 2016
Last Updated
October 27, 2021
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02789553
Brief Title
Starches Digestion After Obesity Surgery.
Acronym
GLUBYPASS
Official Title
Starches Digestion After Obesity Surgery. A Comparative Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Glucose digestion, Bypass surgery, C13-glucose tracer, Insulin secretion
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meal with glucose syrup
Arm Type
Experimental
Arm Description
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
Arm Title
Starch meal
Arm Type
Experimental
Arm Description
Starch meal with 30g mixed in 120 mL of water. It will be consumed in 15 minutes and it represents 30g of glucose
Intervention Type
Other
Intervention Name(s)
First starch meal then meal with glucose syrup
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
First meal with glucose syrup then starch meal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in C13 glucose marker appearance: starch diet.
Description
Appearance of the C13-glucose tracer in the plasma, since the beginning of the diet with the starch diet.
Time Frame
Change from baseline C13 glucose marker appearance at 3 months after surgery
Secondary Outcome Measure Information:
Title
C13 glucose marker appearance: glucose diet.
Description
Appearance of the C13-glucose tracer in the plasma, since the beginning of the diet with the glucose diet.
Time Frame
Change from baseline C13 glucose marker appearance at 3 months after surgery
Title
Insulin secretion
Description
Insulin secretion will be measured with a deconvolution model.
Time Frame
Change from baseline insulin secretion at 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick RITZ, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, metabolic diseases and nutrition
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Starches Digestion After Obesity Surgery.
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