To investigate whether treatment with sulodexide can reverse postprandial dyslipidemia in patients with type 2 diabetes mellitus
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aim of the study is to investigate whether 2 months of oral sulodexide
treatment normalizes postprandial hypertriglyceridemia in patients with DM type
II on statin treatment.
Secondary outcome
The second objective of the present study is to measure the effect of
sulodexide on adipose tissue markers of lipolysis (ANGLPTL3, GPIHBP1 and LPL)
in relation to periferal lipolysis (heparin challenge for LPL release)
Background summary
Type 2 diabetes mellitus (DM2) is associated with changes in
cholesterolmetabolism, resulting in increased (postprandial) triglycide levels.
Although plasma triglyceride levels are associated with increased
cardiovascular risk, there are currently no effective therapies to lower plasma
triglycerides in subjects with type 2 diabetes mellitus. Previous research
from our group has shown that DM2 is associated with decreased endothelial
heparansulfate chains, which normally clear lipids from the circulation. We
thus would like to investigate whether supplementation of oral heparansulfates
normalises postprandial hypertriglyceridemia in subjects with type 2 diabetes
mellitus.
Study objective
To investigate whether treatment with sulodexide can reverse postprandial
dyslipidemia in patients with type 2 diabetes mellitus
Study design
DM2 patients without organdamage and at stable treatment regiment of oral
antidiabetic/cholesterol lowering medication will be randomized to sulodexide
200mg once daily or placebo. At baseline and after 2 months of treatment we
will test efficacy of sulodexide on postprandial triglyceride clearance and
peripheral lipolysis (subcutaneous biopsy) .
Intervention
Sulodexide is a commercially available oral heparanoid compound consisting of
heparan sulphate (80%) and dermatan sulphate (20%)
Study burden and risks
Since our previous study with oral sulodexide (SUGAR study, see Broekhuizen
Diabetologia 2010) which showed almost no side effects upon using sulodiexe, we
thinkt that the increased pathophysiological insight and potential new
therapeutic treatment options using sulodexide for DM2 associated dyslipidemia
outweight the minimum risk (mildly increased bleedingtendency and painfull
bruise after subcutaneous fatbiopsy)
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Male
- Age between 18 and 65 years
- willing to stop ATII/ACE inhibitors 5 days before each lipidload;- oral antidiabetes medication and on statin therapy (no insulin therapy)
Exclusion criteria
- Smoking;- Immunosuppressive drugs;- Serious previous illnesses;- Coagulation disorder;- Primary dyslipidemias;- BMI > 33 kg/m2;- Hypertension (systolic > 140 mm Hg or diastolic > 90 mm Hg);- Cardiovascular disease: ;- AMI;- CVA/ TIA;- AP ;- Intermittent claudication ;- Aneurysms of the aorta
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000381-37-NL |
| CCMO | NL39586.018.12 |