Starches Digestion After Obesity Surgery. (GLUBYPASS)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: First starch meal then meal with glucose syrup; Other: First meal with glucose syrup then starch meal

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Department of Endocrinology, metabolic diseases and nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Meal with glucose syrup; 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	Other: First starch meal then meal with glucose syrup; 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.; Other: First meal with glucose syrup then starch meal; 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.
EXPERIMENTAL: Starch meal; Starch meal with 30g mixed in 120 mL of water. It will be consumed in 15 minutes and it represents 30g of glucose	Other: First starch meal then meal with glucose syrup; 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.; Other: First meal with glucose syrup then starch meal; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline C13 glucose marker appearance at 3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline C13 glucose marker appearance at 3 months after surgery
Insulin secretion	Insulin secretion will be measured with a deconvolution model.	Change from baseline insulin secretion at 3 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 19, 2018
• Primary Completion (ACTUAL): July 2, 2019
• Study Completion (ACTUAL): July 2, 2019

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (ESTIMATE): June 3, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Bypass surgery; Insulin secretion; Glucose digestion; C13-glucose tracer
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 13 196 02; 2015-A01346-43 (OTHER: RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No