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

Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes; Obesity

Intervention: Doxycycline (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
Karen L Herbst, PhD, MD, Principal Investigator, Affiliation: UCSD


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).

Clinical Details

Official title: Blockade of Receptor Cleavage in Diabetes Mellitus With an MMP Inhibitor

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: MMP activity

Secondary outcome: CRP

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- Ambulatory, medically stable, able to give informed consent, and comply with the


- 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


- 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)

Locations and Contacts

University of California San Diego Clinical trials Research Institute, La Jolla, California 92093, United States
Additional Information

Related publications:

DeLano FA, Schmid-Schönbein GW. Proteinase activity and receptor cleavage: mechanism for insulin resistance in the spontaneously hypertensive rat. Hypertension. 2008 Aug;52(2):415-23. doi: 10.1161/HYPERTENSIONAHA.107.104356. Epub 2008 Jul 7.

Starting date: October 2009
Last updated: May 17, 2013

Page last updated: August 23, 2015

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