Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans (DOXY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01375491
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : May 20, 2013
Ruth L. Kirschstein National Research Service Award
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Karen L. Herbst, University of California, San Diego

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Drug: Doxycycline Other: Placebo Phase 4

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Blockade of Receptor Cleavage in Diabetes Mellitus With an MMP Inhibitor
Study Start Date : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Doxycycline
Participants with DM2 receiving doxycycline 100mg BID
Drug: Doxycycline
generic doxycycline 100mg twice daily
Other Name: Vibramycin
Placebo Comparator: Placebo
Pills prepared identical to doxycycline.
Other: Placebo
Placebo comparator to doxycycline

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. CRP [ Time Frame: Day 1 (baseline) and Day 84 ]
    Measure of global inflammation

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ambulatory, medically stable, able to give informed consent, and comply with the protocol.
  • Obesity with BMI >30 kg/m2.
  • DM2 for less than 10 years.
  • 7.5% < HA1C < 10%
  • Taking insulin and/or oral medications (biguanide, sulfonlylurea, etc.)

Exclusion Criteria:

  • Mental states that would preclude complete understanding of the protocol and compliance.
  • Chronic illness such as renal failure (with creatinine clearance <80 ml/min for Specific Aim 2).
  • Women of child-bearing age because of the potential hazard to the fetus (doxycycline may cause permanent discoloration of the teeth and deposition in bone inhibiting growth) and because doxycycline may render oral contraceptives less effective.
  • Nursing mothers.
  • Allergy to tetracyclines.
  • Subjects taking the following drugs: penicillin or it's derivatives, anticoagulant therapy, antacids containing aluminum, calcium, or magnesium, iron-containing preparations, bismuth subsalicylate, barbiturates, carbamazepine, phenytoin or methoxyflurane, thiazolidinediones (TZD)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01375491

United States, California
University of California San Diego Clinical trials Research Institute
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Ruth L. Kirschstein National Research Service Award
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Principal Investigator: Karen L Herbst, PhD, MD UCSD

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karen L. Herbst, Associate Clinical Professor, University of California, San Diego Identifier: NCT01375491     History of Changes
Other Study ID Numbers: 090395
5M01RR000827 ( U.S. NIH Grant/Contract )
P30DK063491 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: May 20, 2013
Last Verified: May 2013

Keywords provided by Karen L. Herbst, University of California, San Diego:
insulin resistance

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents