This study aims to clarify if a tetracycline antibiotic (minocycline) can help the heart and blood vessels in patients with diabetes and who have high levels of a blood protein called Matrix Metalloproteinase-9 (MMP-9).

The Role of Tetracyclines in the Personalised Management of MMP-9 and Cardiovascular Function in Type 2 Diabetes - Tetracyclines in the management of MMP-9 and cardiovascular function in diabetes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002387-16-IE

Enrollment

Unknown

Registered

2015-07-17

Start date

2015-11-16

Completion date

Unknown

Last updated

2017-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II diabetes mellitus MedDRA version: 18.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Minosil SA Product Name: Minocycline hydrochloride Pharmaceutical Form: Capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Treated Type 2 diabetes > 6 months 1562 C>T MMP-9 single nucleotide promoter polymorphism Clinically stable (on same treatment for > 1 month) Willing and able to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Age 3 Upper Limit of Normal) 12. Gastro-oesophageal reflux disease 13. Recent trauma or surgery (<6 months) 14. Malignancy 15. Systemic lupus erythematous (SLE) 16. Myasthenia gravis 17. Subjects with contraindications to MRI (NOTE: if a patient has a contraindication to MRI but is otherwise eligible for enrolment, they may be recruited onto the study. However, they will be excluded from undergoing MRI and this will be clearly highlighted in the patients CRF) a. Hypersensitivity to gadolinium containing contrast agents b. Brain Aneurysm Clip c. Implanted neural stimulator d. Implanted cardiac pacemaker or defibrillator e. Cochlear implant f. Ocular foreign body (e.g. metal shavings) g. Other implanted medical devices: (e.g. Swan Ganz catheter) h. Insulin pump i. Metal shrapnel or bullet.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the impact of one year therapy with minocycline on MMP-9 in patients with with Type 2 diabetes and the MMP-9, 1562 C>T promoter single nucleotide polymorphism ;Secondary Objective: To determine the impact of one year therapy with tetracyclines (minocycline) on markers of inflammation and collagen turnover in patients with Type 2 diabetes and the MMP-9, 1562 C>T promoter single nucleotide polymorphism To assess the impact of one year therapy with tetracyclines (minocycline) on cardiovascular function using ABPM, Pulse Wave Velocity, Retinopathy Assessments, Cardiac MRI and Doppler Echocardiography.;Primary end point(s): Change in serum MMP-9 level following one year therapy with tetracyclines (minocycline) in patients with with Type 2 diabetes and the MMP-9, 1562 C>T promoter single nucleotide polymorphism. ;Timepoint(s) of evaluation of this end point: Baseline (time zero), six months and twelve months	—

Measure

Time frame

Main Objective: To investigate the impact of one year therapy with minocycline on MMP-9 in patients with with Type 2 diabetes and the MMP-9, 1562 C>T promoter single nucleotide polymorphism ;Secondary Objective: To determine the impact of one year therapy with tetracyclines (minocycline) on markers of inflammation and collagen turnover in patients with Type 2 diabetes and the MMP-9, 1562 C>T promoter single nucleotide polymorphism To assess the impact of one year therapy with tetracyclines (minocycline) on cardiovascular function using ABPM, Pulse Wave Velocity, Retinopathy Assessments, Cardiac MRI and Doppler Echocardiography.;Primary end point(s): Change in serum MMP-9 level following one year therapy with tetracyclines (minocycline) in patients with with Type 2 diabetes and the MMP-9, 1562 C>T promoter single nucleotide polymorphism. ;Timepoint(s) of evaluation of this end point: Baseline (time zero), six months and twelve months

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Secondary

Measure	Time frame
Secondary end point(s): Change in serum markers of inflammation, endothelial function and collagen turnover following one year therapy with tetracyclines (minocycline) Change in ABPM, Pulse Wave Velocity, Retinopathy Assessments (e.g. Visual Acuity) and markers of cardiac structure and function on Cardiac MRI and Doppler Echocardiography. ;Timepoint(s) of evaluation of this end point: Baseline (time zero), six months and twelve months (retinopathy and MRI at baseline and 12 months only)	—

Measure

Time frame

Secondary end point(s): Change in serum markers of inflammation, endothelial function and collagen turnover following one year therapy with tetracyclines (minocycline) Change in ABPM, Pulse Wave Velocity, Retinopathy Assessments (e.g. Visual Acuity) and markers of cardiac structure and function on Cardiac MRI and Doppler Echocardiography. ;Timepoint(s) of evaluation of this end point: Baseline (time zero), six months and twelve months (retinopathy and MRI at baseline and 12 months only)

—

Countries

Ireland

Contacts

Public ContactFiona Ryan

Solvotrin Innovations Ltd

Fionaryan@solvotrin.com353214510220

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026