Research with human participants

Overview of medical research in the Netherlands

The effects of doxycycline treatment on inflammation and endothelial function in advanced atherosclerosis

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON23404

Source

NTR

Brief title

N/A

Health condition

atherosclerosis, peripheral arterial disease, inflammation, Doxycycline

Sponsors and support

Primary sponsor :
none
Source(s) of monetary or material Support :
none

Intervention

Outcome measures

Primary outcome

Endothelial function

Secondary outcome

Plasma markers

Background summary

Patients with mild to moderate peripheral arterial disease were treated with doxycycline 100mg daily or placebo.
Reduction in vascular inflammation was assessed by measuring vascular endothelial function and peripheral plasma markers of inflammation.

Study objective

Doxycycline will ameliorate the vascular condition and inflammatory status in patients with mild to moderate atherosclerotic disease

Study design

t=0, follow up after 30, 60, 90 and 120 days

Intervention

Patients were (if necessary) pre-treated with or switched to simvastatin 40 mg daily at least four weeks prior to trial start.
Patients were treated with 100 mg doxycycline for four weeks

Public
Leiden University Medical Center <br>
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Scientific
Leiden University Medical Center <br>
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl

Inclusion criteria

1. Patients suffering from mild to moderate stable peripheral arterial disease who do not require carotis or femoral endarteriectomy (Fontaine IIa)

Exclusion criteria

1. Known hypersensitivity for tetracycline derivates

2. Patients treated with antibiotics in last 3 months for other diseases then lower urinary tract infections

3. Patients treated with immunosuppressive agents (including steroids)

4. Patients treated with fibrates

5. Patients with Diabetes Mellitus regulated with drug therapy

6. Signs of kidney or liver failure

Design

Study type :
Interventional
Intervention model
:
Crossover
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
15
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL1331
NTR-old NTR1389
Other METC LUMC : P05.189
ISRCTN ISRCTN wordt niet meer aangevraagd

Summary results

In progress