Phase 4
Completed N=39
Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans
Source: ClinicalTrials.gov NCT01375491 ↗Enrolled (actual)
39
Serious AEs
—
Results posted
Jan 2020
Primary outcomePrimary: MMP Activity — 56.8; 43.8; 47.2 uM 5-FAM/h-ug protein
◆ Published Evidence
Established
35citations · ~3 / year
Proof of Concept: Matrix metalloproteinase inhibitor decreases inflammation and improves muscle insulin sensitivity in people with type 2 diabetes.
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).
Linked Publications
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Proof of Concept: Matrix metalloproteinase inhibitor decreases inflammation and improves muscle insulin sensitivity in people with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MMP Activity |
59.7; 56.6 | — |
| PRIMARY MMP Activity |
59.7; 56.6 | — |
| SECONDARY CRP |
2.3; 6.2 | — |
| SECONDARY CRP |
2.3; 6.2 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01375491) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.