The primary objective of this study is to assess the efficacy of endoscopic gastric reduction with the endomina® device, in combination with standard of care, compared to standard of care alone, on the remission of diabetes 24 months after surgery, in patients with type-2 diabetes and class I obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Endoscopic gastroplasty
Chu Grenoble Alpes
La Tronche, France
RECRUITINGRemission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity
Remission is defined as HbA1c \< 6.5% without antidiabetic drug for at least 3 months
Time frame: 24 months
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