Comparative evaluation of the effect of Atorvastatin and Rosuvastatin on Bone Health Parameters in Patients with Type 2 Diabetes Mellitus on statin therapy: A Cross-Sectional Analytical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- This study will help to identify the effects and potential differences between atorvastatin and rosuvastatin on bone health parameters like bone mineral density and bone forming marker - P1NP in patients with type 2 diabetes mellitus. The research will also give an insight on how the duration and doses of the medications create an impact on overall health of the bone.
研究概览
简要总结
Type 2 diabetes mellitus(T2DM) is a chronic metabolic disorder characterized by elevated blood glucose levels due to insulin
resistance and insulin deficiency. T2DM significantly increases the risk of cardiovascular disease (CVD), making it a leading cause
of morbidity and mortality among individuals with diabetes. Statins, which have been commonly prescribed as a prophylaxis to
prevent CVD in diabetic patients, have proven to have pleiotropic effects on bone health. Some studies report increased bone
mineral density (BMD) and bone forming markers (P1NP) with statin use, while other studies show no significant effects or even a
negative association at higher doses. A study comparing the effects of atorvastatin and rosuvastatin in post menopausal women
found significant decrease in P1NP levels after 12 months of rosuvastatin use, whereas the patients on atorvastatin did not exhibit
decline in P1NP. This suggests a potential advantage of atorvastatin over rosuvastatin in preserving bone formation activity. While
statins are effective in reducing cardiovascular risk, their impact on glycemic control is significant. Higher doses of atorvastatin may
cause insulin resistance, while other statins like pravastatin have shown a more favourable glycemic profile. This study will enhance
current understanding by providing insights into the effects of atorvastatin and rosuvastatin on bone health in patients with type 2
diabetes mellitus on statin therapy. This research can enhance clinical guidelines and optimize statin selection for patients with
T2Dm aiming for comprehensive management of their cardio metabolic and skeletal health.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant age must be above 40 years Previously diagnosed case of type 2 diabetes mellitus Participants must currently be either on atorvastatin or rosuvastatin for atleast 1.5 yrs (18 months or more) Participants who have given written informed consent for the study.
排除标准
- •Patients with a known case of any bone-related diseases (e.g., osteoporosis, osteopenia) Patients who are already on any bone-modifying medications (e.g., SGLT-2 Inhibitors, thiazolidinediones, insulin, bisphosphonates, calcium and vitamin D supplementation) Patient who are having a history of any uncontrolled chronic disorder – renal, liver disease Post menopausal women Pregnant and breastfeeding women.
结局指标
主要结局
This study will help to identify the effects and potential differences between atorvastatin and rosuvastatin on bone health parameters like bone mineral density and bone forming marker - P1NP in patients with type 2 diabetes mellitus. The research will also give an insight on how the duration and doses of the medications create an impact on overall health of the bone.
时间窗: Being a cross-sectional study, the outcomes namely BMD and P1NP will be measured once at the time of enrolment in patients who have been taking Atorvastatin or Rosuvastatin for 18 months or more.
次要结局
未报告次要终点
研究者
Dr Shilpa P
AIIMS Mangalagiri