Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
05/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr L N Broekhuizen

ORCID ID

Contact details

Academic Medical Center (AMC) Amsterdam
Department of Vascular Medicine
F4-142
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
L.N.Broekhuizen@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

SUGAR

Study hypothesis

Primary Objective:
Aim of the study is to investigate whether sulodexide treatment reverses damage of the systemic glycocalyx in patients with Diabetes Mellitus type two (DM type II). The effect of sulodexide will be addressed in this prospective cross-over study measuring systemic and local glycocalyx volume, vascular permeability as well as endothelial function in patients with DM type II who have microalbuminuria and in patients with DM type II who do not have microalbuminuria.

Secondary Objective(s):
The second objective of the present study is to measure the effect of sulodexide on biochemical parameters, including micro-albuminuria and HBA1c, in patients with DM type II with and without microalbuminuria.

Ethics approval

The study has been approved by the medical ethics commission of the Academic Medical Centre on December 20, 2006 (ref: MEC 06/ 228).

Study design

Randomised, placebo controlled, crossover, single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetes Mellitus type two (DM type II)

Intervention

Sulodexide versus placebo.

Patients with DM type II and healthy volunteers will visit the hospital on four occasions:
1. Screening-inclusion visit
2. End of study period I
3. End of washout visit
4. End of study period II

At the end of each study period, we will evaluate glycocalyx volume and vascular permeability using dextran-40 and albumine-I125 for estimation of perm- versus charge selectivity. In addition, we will evaluate vascular function as well as routine laboratory parameters, including micro-albuminuria and safety parameters.

Intervention type

Drug

Phase

Not Specified

Drug names

Sulodexide

Primary outcome measures

The difference in systemic glycocalyx volume after sulodexide and after placebo treatment.

Secondary outcome measures

1. The difference in systemic glycocalyx volume after sulodexide and after placebo treatment in local sublingual glycocalyx volume, vascular permeability and endothelial function in all patients.
2. The percentage change from baseline to end of the study in microalbuminuria in patients with DM type II who have microalbuminuria.

Overall trial start date

01/11/2006

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. Age between 18 and 65 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

26

Participant exclusion criteria

1. Smoking
2. Immunosuppressive drugs
3. Serious previous illnesses
4. Coagulation disorders
5. Primary dyslipidemias
6. Body Mass Index (BMI) more than 30 kg/m^2
7. Hypertension (systolic more than 140 mmHg or diastolic more than 90 mmHg)

Recruitment start date

01/11/2006

Recruitment end date

01/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC) Amsterdam
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Department of Vascular Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/#http://www.amc.uva.nl/

Funders

Funder type

Industry

Funder name

Alfa Wassermann (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20865240

Publication citations

  1. Results

    Broekhuizen LN, Lemkes BA, Mooij HL, Meuwese MC, Verberne H, Holleman F, Schlingemann RO, Nieuwdorp M, Stroes ES, Vink H, Effect of sulodexide on endothelial glycocalyx and vascular permeability in patients with type 2 diabetes mellitus., Diabetologia, 2010, 53, 12, 2646-2655, doi: 10.1007/s00125-010-1910-x.

Additional files

Editorial Notes