Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03038373 |
| Other study ID # |
RA-2011-014 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2012 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
October 2021 |
| Source |
Dasman Diabetes Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes
in the morbid obese patients after laparoscopic sleeve gastrectomy.
Description:
In this study four groups including: Group I - Morbid Obese Diabetics, Group II - Morbid
Obese Non Diabetics, Group III - Lean Diabetics, and Group IV - Lean Non Diabetics will be
studies. The bariatric surgical procedure should include Laparoscopic Sleeve Gastrectomy
(LSG). All participants will be assessed by members of a multidisciplinary obesity team
including a surgeon, endocrinologist, dietician, and nurse specialist who will usually have
input into patient selection.
Briefly the study will be explained to the each participant, and after his/her agreement, the
informed Consent Form will be deliver to him/her for completion and signature. Within a week
before surgery each enrolled participant of group I and II will be subjected to a medical
questionnaire and other routine laboratory analyses before surgery such as fasting glucose,
liver, renal, lipid and coagulation profiles. At this time a Mixed Meal Tolerance Test (MMTT)
will be performed and blood samples will be collected for further analysis as it is described
in the protocol.
Participants in group I and II will be admitted at Dasman Diabetes Institute for post-surgery
follow up, performing MMTT, and donating blood samples on days 07, 15, 30, 60, 90, 180, and
360 post-surgery. Adipose, muscle biopsies, and a sample from remnant surgical tissue from
these participants will be harvested during of the LSG (days 0). Participants in group I will
be asked to monitor their fasting blood glucose level everyday at early morning and the dose
of anti-hyperglycemia medications will be adjusted by the recommendation provided by the
physician member of team. This data will be recorded as their continuous blood glucose
monitoring.
Group III and IV participants, as control groups with no surgical intervention, will be
subjected to the medical questionnaire and other routine laboratory analyses and MMTT in just
one visit.
All demographic and clinical information collected from the participants will be recorded in
the information form identified by identification number (ID number). Only samples from the
cases that do not have any post-surgery related complications or not have any emergency
clinical condition will be used for genomics and proteomics analysis.
