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

University of California San Diego

Status and phase

Completed

Phase 4

Conditions

Obesity

Type 2 Diabetes

Treatments

Other: Placebo

Drug: Doxycycline

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01375491

P30DK063491 (U.S. NIH Grant/Contract)

5M01RR000827 (U.S. NIH Grant/Contract)

090395

Details and patient eligibility

About

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).

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)