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 |
| Protocol serial number | 1 |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | Alfa Wassermann (Italy) |
- 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
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, crossover, single blinded trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sulodexide |
| Primary outcome measure(s) |
The difference in systemic glycocalyx volume after sulodexide and after placebo treatment. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 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
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
