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Obesity Surgery
Published in: Obesity Surgery 2/2017

01-02-2017 | Original Contributions

MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy

Authors: Karl Miller, R. Turró, J. W. Greve, C. M. Bakker, J. N. Buchwald, J. C. Espinós

Published in: Obesity Surgery | Issue 2/2017

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Abstract

Background

Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported.

Methods

Subjects with classes I–II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months.

Results

From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred.

Conclusions

In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters.
Study registration: clinicaltrials.gov identifier # NCT01843231
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Metadata
Title
MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy
Authors
Karl Miller
R. Turró
J. W. Greve
C. M. Bakker
J. N. Buchwald
J. C. Espinós
Publication date
01-02-2017
Publisher
Springer US
Published in
Obesity Surgery / Issue 2/2017
Print ISSN: 0960-8923
Electronic ISSN: 1708-0428
DOI
https://doi.org/10.1007/s11695-016-2295-9

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