SLEEVEDIAB To Explore the Early and Late Metabolic Effects of Sleeve Gastrectomy in Obese Patients (SLEEVEDIAB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02076880|
Recruitment Status : Unknown
Verified September 2013 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : March 4, 2014
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Severe Obesity Type 2 Diabetes||Other: Caloric restriction Other: No caloric restriction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of Endocrin-metabolic Modifications Related to Diabetes Improvement After Sleeve Gastrectomy in Severly Obese|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2017|
Experimental: Arm with caloric restriction
Patients in this arm will have, during 7 days before surgery, a caloric restriction of 1000 kcal per day compared to the usual food intake. They will be hospitalized during this period.
Intervention: caloric restriction
Other: Caloric restriction
Caloric restriction of 1000 kcal per day compared to the usual food intake.
Experimental: Arm without caloric restriction
Patients in this arm will not have a caloric restriction before surgery.
Intervention: No caloric restriction
Other: No caloric restriction
No change in eating habits to patients in this arm
- Change of area under the curve of post prandial glycemia [ Time Frame: Baseline to day 7 after surgery ]
- Change in insulin sensitivity, Change in insulin secretion, Change in incretins [ Time Frame: Blood samples at D-15, D-7 before surgery, D7, D80, D170, D350 after surgery ]
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): NCT02076880
|Contact: Florence GALTIER, MDemail@example.com|
|Contact: Eric RENARD, PU-PHfirstname.lastname@example.org|
|Montpellier, France, 34295|
|Contact: GALTIER Florence email@example.com|
|Principal Investigator: GALTIER Florence, MD|
|Principal Investigator:||Florence GALTIER, MD||Montpellier University Hospital|