Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans (DOXY)
Obesity is a heightened state of inflammation in which production of cytokines and matrix metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes (DM2).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Blockade of Receptor Cleavage in Diabetes Mellitus With an MMP Inhibitor|
- MMP activity [ Time Frame: Day 1 (baseline) and Day 84 ] [ Designated as safety issue: No ]MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9
- CRP [ Time Frame: Day 1 (baseline) and Day 84 ] [ Designated as safety issue: No ]Measure of global inflammation
|Study Start Date:||October 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Participants with DM2 receiving doxycycline 100mg BID
generic doxycycline 100mg twice daily
Other Name: Vibramycin
Placebo Comparator: Placebo
Pills prepared identical to doxycycline.
Placebo comparator to doxycycline
Design and Setting: 84 day (D84), double-blind, randomized, placebo (PL)-controlled clinical trial conducted in an academic tertiary care center.
Patients: Non-DM2 Controls (n=15); participants with DM2 receiving PL (n=13) or DOX (n=11).
Interventions: All participants were evaluated at day 1 (D1); those with DM2 were also evaluated at D84 after DOX 100mg twice daily or PL.
|United States, California|
|University of California San Diego Clinical trials Research Institute|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Karen L Herbst, PhD, MD||UCSD|