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COMPLETEDPhase 4NCT01375491

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

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 ...

Lead sponsor: University of California, San Diego•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of California, San Diego

Collaborators

Ruth L. Kirschstein National Research Service Award
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)

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.

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 13, 2020Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment39

Start dateOct 2009

Last updatedJan 13, 2020

Condition

Type 2 Diabetes Obesity

Locations shown

University of California San Diego Clinical trials Research Institute

La Jolla, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2020Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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