Starches Digestion After Obesity Surgery.

NCT02789553 | Completed

• 2 other identifiers: 13 196 022015-A01346-43
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Glucose digestion; Bypass surgery; C13-glucose tracer; Insulin secretion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• C13 glucose marker appearance: glucose diet.

  Change from baseline C13 glucose marker appearance at 3 months after surgery

• Insulin secretion

  Change from baseline insulin secretion at 3 months after surgery

Study Arms (2)

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

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

Other: First starch meal then meal with glucose syrup; Other: First meal with glucose syrup then starch meal

Interventions

First starch meal then meal with glucose syrup OTHER

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.

Meal with glucose syrup; Starch meal

First meal with glucose syrup then starch meal OTHER

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.

Meal with glucose syrup; Starch meal

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Department of Endocrinology, metabolic diseases and nutrition

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick RITZ, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: June 3, 2016
• Study Start: February 19, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)