Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans (DOXY)
|ClinicalTrials.gov Identifier: NCT01375491|
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : May 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Obesity||Drug: Doxycycline Other: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Blockade of Receptor Cleavage in Diabetes Mellitus With an MMP Inhibitor|
|Study Start Date :||October 2009|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
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
- MMP activity [ Time Frame: Day 1 (baseline) and Day 84 ]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 ]Measure of global inflammation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375491
|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|