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

This study has been completed.
Sponsor:
Collaborators:
Ruth L. Kirschstein National Research Service Award
Information provided by (Responsible Party):
Karen L. Herbst, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01375491
First received: May 25, 2011
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes
Obesity
Drug: Doxycycline
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Blockade of Receptor Cleavage in Diabetes Mellitus With an MMP Inhibitor

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • MMP activity [ Time Frame: Day 1 (baseline) and Day 84 ] [ Designated as safety issue: No ]
    MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9


Secondary Outcome Measures:
  • CRP [ Time Frame: Day 1 (baseline) and Day 84 ] [ Designated as safety issue: No ]
    Measure of global inflammation


Enrollment: 50
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxycycline
Participants with DM2 receiving doxycycline 100mg BID
Drug: Doxycycline
generic doxycycline 100mg twice daily
Other Name: Vibramycin
Placebo Comparator: Placebo
Pills prepared identical to doxycycline.
Other: Placebo
Placebo comparator to doxycycline

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01375491

Locations
United States, California
University of California San Diego Clinical trials Research Institute
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Ruth L. Kirschstein National Research Service Award
Investigators
Principal Investigator: Karen L Herbst, PhD, MD UCSD
  More Information

Publications:
Responsible Party: Karen L. Herbst, Associate Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01375491     History of Changes
Other Study ID Numbers: 090395, 5M01RR000827, P30DK063491
Study First Received: May 25, 2011
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
doxycycline
insulin resistance
obesity
inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014