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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Doxycycline

Participants with DM2 receiving doxycycline 100mg BID

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

generic doxycycline 100mg twice daily

Placebo

Pills prepared identical to doxycycline.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo comparator to doxycycline

Interventions

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Doxycycline

generic doxycycline 100mg twice daily

Intervention Type DRUG

Placebo

Placebo comparator to doxycycline

Intervention Type OTHER

Other Intervention Names

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Vibramycin

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes