The effects of statin therapy on the osteoprotegerin-RANKL system, correlation with vascular disease and bone metabolism in patients with Type 2 diabetes.

Conditions: We hope to elucidate whether statins affect levels of serum OPG in Type 2 Diabetic patients, and if they have any effect on indices of arterial stiffness.Furthermore, statins have been shown to increase bone mineral density, and we wish to investigate this with regards to patients with diabetes by observing their effect on markers of bone turnover and by performing DXA scans.
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

Registration Number: EUCTR2007-004368-34-IE

Lead Sponsor: Department of Academic Endocrinology, Beaumont Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

Age > 40 years
Type 2 diabetes
HbA1c <7.5%
No change in diabetic treatment in last 3 months
Stain naïve or currently on no more than 10mg atorvastatin, 40mg pravastatin, or 20mg simvastatin.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age < 40 years
Intolerance to statin therapy
Significant hepatic disease precluding statin therapy
Current use of > 10mg atorvastatin, 40mg pravastatin, or 20mg simvastatin
Type 1 diabetes mellitus
Women of child bearing potential
Pregnant women
Renal dysfunction, defined as a creatinine greater than 150µmol/l
History of or current malignancy
Treatment with agents known to interfere with OPG/RANKL system such as bisphosphonates, vitamin D, strontium
Recent (3 months) change in diabetes treatment
Recent vertebral or non-vertebral fracture in the last 6 months
Recent (within last 6 months) cardiovascular or cerebrovascular event
Recent (within last 6 months) coronary angioplasty
Children/Minors (<18 years of age)
Unable to read or give informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of statin therapy on OPG/RANKL levels in patients with type 2 diabetes.;Secondary Objective: To assess whether statin therapy reduces arterial stiffness in patients with type 2 diabetes.<br><br>To establish the effect of statins on bone metabolism in patients with type 2 diabetes.;Primary end point(s): Primary endpoint: Serum sample for OPG and RANKL<br><br>Serum sample for TRAIL (TNF-related apoptosis-inducing ligand)<br>Pulse-wave velocity <br>Body mass index<br>Waist circumference<br>Glycosylated haemoglobin<br>Fasting plasma glucose<br>Fasting lipid profile<br>Fasting insulin and C-peptide for calculation of HOMA analysis<br>Serum sample for Bone Alkaline Phosphatase, P1NP and C-TX, PTH and Vit D<br>DXA scan for bone-mineral density<br>

Secondary Outcome Measures