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

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.

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)