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Starches Digestion After Obesity Surgery. (GLUBYPASS)

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ClinicalTrials.gov Identifier: NCT02789553
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Obesity Other: First starch meal then meal with glucose syrup Other: First meal with glucose syrup then starch meal Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Starches Digestion After Obesity Surgery. A Comparative Study.
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. C13 glucose marker appearance: glucose 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 glucose diet.

  2. Insulin secretion [ Time Frame: Change from baseline insulin secretion at 3 months after surgery ]
    Insulin secretion will be measured with a deconvolution model.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789553


Contacts
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Contact: Patrick RITZ, MD 0561323734 ritz.p@chu-toulouse.fr

Locations
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France
Department of Endocrinology, metabolic diseases and nutrition Recruiting
Toulouse, France, 31059
Contact: Patrick Ritz, MD, PhD    0567771638 ext +33    ritz.p@chu-toulouse.fr   
Contact: Amandine Pauze    0561778434 ext +33    pauze.a@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Patrick RITZ, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02789553     History of Changes
Other Study ID Numbers: 13 196 02
2015-A01346-43 ( Other Identifier: RCB )
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Glucose digestion
Bypass surgery
C13-glucose tracer
Insulin secretion
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms