NCT02285985

Effects of Saxagliptin on Adipose Tissue Inflammation in Humans

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Phoenix VA Health Care System · Federal
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In this research study, Investigators will be comparing the effects of a medication Saxagliptin versus placebo (a similar looking pill that contains no medication) on inflammation in the body. Research Hypothesis DPP-4 inhibition by saxagliptin (ONGLYZA™) reduces adipose tissue inflammation in obese individuals and this is characterized by decreases in a) reactive oxygen species (ROS) production, b) toll-like receptors (TLR) and NF-kappa B pathway activation, c) expression of pro-inflammatory genes, d) macrophage infiltration, and e) secretion of pro-inflammatory factors.

Detailed description

This is a randomized, prospective, double-blind study. Randomization to Saxagliptin and placebo will be in a 2:1 fashion. Treatment duration will be approximately 6 weeks.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Saxagliptin	Tablets: 5 mg
DRUG	Placebo	Tablets: 5mg

Timeline

• Start date: 2013-02-01
• Primary completion: 2019-10-12
• Completion: 2019-10-12
• First posted: 2014-11-07
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States