Endobarrier Treatment in Obese Subjects With T2DM
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|ClinicalTrials.gov Identifier: NCT01718457|
Recruitment Status : Unknown
Verified June 2014 by Sheba Medical Center.
Recruitment status was: Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : July 1, 2014
Diabesity (Diabetes accompanied by obesity) is a prevalent condition many times complicated by micro- and macrovascular disease. Many treatments for Diabesity paradoxically cause further weight gain and hypoglycemia. The Endobarrier enables diabetes control along with weight loss as an alternative to bariatric surgery for patients who are not interested or not qualified for surgery. The aim of this study is to assess the efficacy and safety of the Endobarrier Diabesity patients in Israel.
This study will include 45 men and women between the ages of 18-65 with HbA1c level of 8% and above and a BMI of 30 kg/m2 or above.
Exclusion criteria: use of anti-coagulant, use of steroids or inability to discontinue these medications.
The cohort will be followed for two years during which the patients will be monitored for diabetes control (by using a continuous glucose monitor), weight, blood pressure, lipid profile, fatty liver (by Ultrasound and blood markers for inflammation and fibrosis) and change in plasma gut peptide levels. The Endobarrier will be explanted after one year, however the monitoring of the patients will continue for another year.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Obesity||Device: Endobarrier||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endobarrier Treatment in Obese Subjects With T2DM|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||January 2018|
|Experimental: Endobarrier device insertion||
Other Name: Duodenal-Jejunal Bypass Liner
- percent change in HbA1c level [ Time Frame: 1 year, 2 years ]
- percent change in BMI [ Time Frame: 1 year, 2 years ]
- percent change in LDL cholesterol levels [ Time Frame: 1 year, 2 years ]
- change in waist circumference [ Time Frame: 1 year, 2 years ]
- change in fasting plasma glucose level [ Time Frame: 1 year, 2 years ]
- percent change in HDL cholesterol levels [ Time Frame: 1 year, 2 year ]
- percent in Triglycerides levels [ Time Frame: 1 year, 2 years ]
- change in degree of fatty liver [ Time Frame: 1 year, 2 years ]liver enzymes, liver ultrasound, fibromax tests
- change in plasma gut peptide levels [ Time Frame: 1 year, 2 years ]GLP-1, PYY, Oxynthomodulin, Ghrelin
- change in plasma insulin level [ Time Frame: 1 year, 2 years ]
- change in C-peptide levels [ Time Frame: 1 year, 2 years ]
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): NCT01718457
|Sheba medical center, Tel-Hashomer|
|Ramat-Gan, Israel, 52621|
|Principal Investigator:||Gabriella Segal-Lieberman, MD||Sheba Medical Center|