PMID- 37916028
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231103
IS  - 2042-0188 (Print)
IS  - 2042-0196 (Electronic)
IS  - 2042-0188 (Linking)
VI  - 14
DP  - 2023
TI  - Design and rationale for the SIB trial: a randomized parallel comparison of 
      semaglutide versus placebo on intestinal barrier function in type 2 diabetes 
      mellitus.
PG  - 20420188231207348
LID - 10.1177/20420188231207348 [doi]
LID - 20420188231207348
AB  - OBJECTIVE: To describe the rationale and design of the SIB trial, an 
      interventional clinical trial testing the hypothesis that subcutaneous (s.c.) 
      once-weekly semaglutide can improve intestinal permeability and reduce systemic 
      inflammation in participants with type 2 diabetes (T2D) and obesity. METHODS: SIB 
      (NCT04979130) is an investigator-initiated, single-center randomized, 
      double-blinded, placebo-controlled clinical study being conducted at the 
      University of Colorado Anschutz Medical Campus. The primary objective of this 
      novel trial is to test the hypothesis that subcutaneous (s.c.) once-weekly 
      semaglutide could improve intestinal permeability and reduce systemic 
      inflammation in participants with T2D and obesity. Eligible participants had a 
      diagnosis of type 2 diabetes, elevated body mass index, and evidence of systemic 
      inflammation. Participants were randomized 1:1 to s.c. semaglutide or placebo. 
      Participants were assessed for intestinal permeability and markers of 
      inflammation at baseline, mid-study, and at the end of the study. Efficacy 
      assessments were based on the analysis of the following: lactulose:mannitol ratio 
      test, serum lipopolysaccharide-binding protein (LBP), fecal calprotectin, 
      inflammatory biomarkers (IL-6, TNF, IL-1, IL-8, hs-CRP), and HbA1c. All 
      participants who enrolled in the trial provided written informed consent after 
      having received written and oral information on the trial. The risks of 
      semaglutide use were minimized by administration according to FDA-labeled use and 
      close monitoring for adverse events. DISCUSSION: SIB is the first study to 
      examine the effects of GLP-1 receptor agonists on intestinal permeability in 
      humans and will provide important data on their impact on systemic inflammation 
      and intestinal permeability in the setting of T2D and obesity.
CI  - (c) The Author(s), 2023.
FAU - Rella, Steven
AU  - Rella S
AUID- ORCID: 0000-0002-8579-705X
AD  - Division of Endocrinology, Metabolism and Diabetes, University of Colorado 
      Anschutz Medical Campus, Mail Stop 8106, 12631 East 17th Avenue, Aurora, CO 
      80045-2559, USA.
FAU - Onyiah, Joseph
AU  - Onyiah J
AD  - University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
FAU - Baker, Chelsea
AU  - Baker C
AUID- ORCID: 0000-0002-9807-7115
AD  - University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
FAU - Singh, Vatsala
AU  - Singh V
AD  - University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
FAU - Her, Andrew
AU  - Her A
AD  - University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
FAU - Rasouli, Neda
AU  - Rasouli N
AD  - University of Colorado Denver - Anschutz Medical Campus, Aurora, CO, USA.
LA  - eng
PT  - Journal Article
DEP - 20231029
PL  - United States
TA  - Ther Adv Endocrinol Metab
JT  - Therapeutic advances in endocrinology and metabolism
JID - 101532143
PMC - PMC10617296
OTO - NOTNLM
OT  - diabetes mellitus type 2
OT  - intestinal permeability
OT  - semaglutide
OT  - systemic inflammation
EDAT- 2023/11/02 06:42
MHDA- 2023/11/02 06:43
PMCR- 2023/10/29
CRDT- 2023/11/02 04:12
PHST- 2023/01/31 00:00 [received]
PHST- 2023/09/26 00:00 [accepted]
PHST- 2023/11/02 06:43 [medline]
PHST- 2023/11/02 06:42 [pubmed]
PHST- 2023/11/02 04:12 [entrez]
PHST- 2023/10/29 00:00 [pmc-release]
AID - 10.1177_20420188231207348 [pii]
AID - 10.1177/20420188231207348 [doi]
PST - epublish
SO  - Ther Adv Endocrinol Metab. 2023 Oct 29;14:20420188231207348. doi: 
      10.1177/20420188231207348. eCollection 2023.