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Clinical Trial Details

Trial ID: L1819
Source ID: NCT04979130
Associated Drug: Semaglutide
Title: Comparing Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB)
Acronym: SIB
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Chronic Inflammation|Intestinal Permeability
Interventions: DRUG: Semaglutide|DRUG: Placebo
Outcome Measures: Primary: Differences in lactulose mannitol ratio (LMR) test as a measure of intestinal permeability between treatment groups, The ratio of lactulose to mannitol will be measured in urine collected within 6 hours after ingestion of dual sugar. This ratio predominantly reflects small intestine permeability., Week 16 (visit 6) | Secondary: Differences between treatment groups in plasma LBP, Marker of intestinal permeability, Week 8 (visit 4), Week 16 (visit 6)|Differences between treatment groups in Serum zonulin, Marker of intestinal permeability, Week 8 (visit 4), Week 16 (visit 6)|Differences between treatment groups in Fecal Calprotectin, Marker of intestinal inflammation, Week 8 (visit 4), Week 16 (visit 6)|Differences between treatment groups in plasma IL-6, Marker of chronic inflammation, Week 8 (visit 4), Week 16 (visit 6)|Differences between treatment groups in plasma IL-8, Marker of chronic inflammation, Week 8 (visit 4), Week 16 (visit 6)|Differences between treatment groups in plasma TNFα, Marker of chronic inflammation, Week 8 (visit 4), Week 16 (visit 6)|Differences between treatment groups in plasma hs-CRP, Marker of chronic inflammation, Week 8 (visit 4), Week 16 (visit 6) | Other: Exploratory: determine the effect of semaglutide as compared to placebo on intestinal microbiota in relation to changes in intestinal permeability and inflammatory markers, Microbiome study, Visit 6 (week 16)
Sponsor/Collaborators: Sponsor: University of Colorado, Denver | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 69
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-01-01
Completion Date: 2024-10-16
Results First Posted:
Last Update Posted: 2025-03-20
Locations: University of Colorado Anschutz, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT04979130