Effects of SUlodexide on damaged endothelial Glycocalyx in pAtients with diabetes Mellitus type two: Reversing damage

ISRCTN	ISRCTN82695186
DOI	https://doi.org/10.1186/ISRCTN82695186
Secondary identifying numbers	1

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 05/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L N Broekhuizen
Scientific

Academic Medical Center (AMC) Amsterdam
Department of Vascular Medicine, F4-142
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Email	L.N.Broekhuizen@amc.uva.nl

Study information

Study design	Randomised, placebo controlled, crossover, single blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	SUGAR
Study objectives	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(s)	The study has been approved by the medical ethics commission of the Academic Medical Centre on December 20, 2006 (ref: MEC 06/ 228).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sulodexide
Primary outcome measure	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 study start date	01/11/2006
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	26
Key inclusion criteria	1. Male 2. Age between 18 and 65 years
Key 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)
Date of first enrolment	01/11/2006
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC) Amsterdam

Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

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

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Industry

Alfa Wassermann (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2010		Yes	No