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Clinical Trial Details

Trial ID: L5619
Source ID: NCT02285985
Associated Drug: Saxagliptin
Title: Effects of Saxagliptin on Adipose Tissue Inflammation in Humans
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Saxagliptin|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in the secretion of cytokines/adipokines by adipose tissue, The primary objective is to determine whether 6 weeks of treatment with saxagliptin, compared to placebo, causes a reduction from baseline in the production and secretion of cytokines/adipokines by adipose tissue, 6 weeks | Secondary: reduction from baseline in tissue measures of inflammation, The secondary objective is to determine whether 6 weeks of treatment with saxagliptin, compared to placebo, causes a reduction from baseline in reactive oxygen production, pro-inflammatory gene expression, toll-like receptor and nuclear factor-kappa B activation, and macrophage infiltration in adipose tissue of obese individuals, 6 weeks|change in plasma postprandial lipids, We will also compare the change in postprandial lipids following a standard meal between placebo and saxagliptin, 6 weeks|change in reactive hyperemic index, We will use peripheral artery tonometry to measure the change in endothelial function by measuring reactive hyperemic index, 6 weeks | Other: change in percent arteriole dilation, Using arterioles isolated from tissue biopsies, we will measure dose related responses to distinct dilators, 6 weeks
Sponsor/Collaborators: Sponsor: Phoenix VA Health Care System | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 103
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-02
Completion Date: 2019-10-12
Results First Posted:
Last Update Posted: 2024-07-22
Locations: Carl T. Hayden VA Medical Hospital, Phoenix, Arizona, 85012, United States
URL: https://clinicaltrials.gov/show/NCT02285985