BACKGROUND: The aim of this study was to demonstrate feasibility and safety of a new @entity262 ( @entity262 , BALANCE) in @entity1 . Secondary objectives were to evaluate the effect on glycemic control and @entity353 in @entity1 with @entity28 and @entity6 ( @entity6 ). METHODS: In an open-labeled, prospective, single-arm, non-randomized multicenter study, 12 @entity28 @entity6 @entity1 with a mean @entity4051 c of 8.0  % received laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, @entity65 , and weight were collected. The follow-up period after implantation was 12  months. RESULTS: Device related severe adverse events did not occur. Mean HbA1c decreased by 0.8  % (p   =   0.02) and mean fasting blood @entity413 level (FBG) was reduced by 19  % (p   =   0.038) after the 12  months. Mean HDL level increased from 44 to 48  mg/dl (p   =   0.033). CONCLUSIONS: @entity262 is a feasible and safe procedure. Positive effects on @entity6 and some @entity65 (HDL, weight) were seen. However, further prospective randomized blinded studies are needed in order to evaluate the potential of this new minimally invasive method.

Duodenal Electric Stimulation : Results of a First-in- XXXX Study.

@entity1 :: ('9606', 'Species') :: ['humans', 'patients'] @entity4051 :: ('3039', 'Gene') :: ['HbA1'] @entity353 :: ('MESH:D015431', 'Disease') :: ['weight loss'] @entity6 :: ('MESH:D003920', 'Disease') :: ['T2DM', 'type 2 diabetes mellitus'] @entity28 :: ('MESH:D009765', 'Disease') :: ['obese', 'obesity'] @entity262 :: ('MESH:D034721', 'Disease') :: ['electric duodenal stimulation system', 'EDS'] @entity413 :: ('MESH:D005947', 'Chemical') :: ['glucose'] @entity65 :: ('MESH:D002318', 'Disease') :: ['cardiovascular parameters']
@entity1 :: (9606,Species) :: ['Man']
