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