Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02789553 |
| Other study ID # |
13 196 02 |
| Secondary ID |
2015-A01346-43 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 19, 2018 |
| Est. completion date |
July 2, 2019 |
Study information
| Verified date |
October 2021 |
| Source |
University Hospital, Toulouse |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
