Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- change in testosterone level after atorvastatin treatment
研究概览
简要总结
The aim of the study was to assess the effect of high intensity statin therapy on testicular and adrenal steroids and vitamin D levels in type 2 diabetes males.It is a prospective study, conducted between march 2021 and July 2022, including 60 men with type 2 diabetes, aged 40 - 65 years, statin-free, and in whom a treatment with high intensity statin was indicated. The patients had two visits, before and six months after a daily intake of 40 mg of atorvastatin. During each visit, they underwent a clinical examination including the Androgen Deficiency in the Aging Male (ADAM) questionnaire and a fasting blood sample was collected for biological and hormonal measurements.
详细描述
Study design and setting It is a prospective study carried out at the department of Endocrinology of the University Hospital La Rabta, Tunis, between March 2021 and July 2022. The protocol was approved by La Rabta University Hospital local ethics committee.
Subjects Inclusion criteria were male subjects, aged between 40 and 65 years, with T2D, naive to statin and in whom a high intensity statin therapy was indicated according to the recommendations of the American Diabetes Association 2021 i.e in secondary cardio-vascular prevention or in primary prevention if the patient was aged more than 50 years or if other atherosclerotic cardiovascular disease risk factors were associated.
All patients gave an informed written consent to participate in the study. Exclusion criteria were the use within the last six months of drugs interfering with steroidogenesis (androgens, anti-androgens, Gn-RH analogues, corticosteroids, antiepileptics, barbiturates or other enzyme inducer or inhibitor); history of endocrinopathy (hypogonadism, testicular tumor, pituitary insufficiency, adrenal insufficiency, uncontrolled hypothyroidism); history of severe systemic disease (hepatic insufficiency, cirrhosis, alcoholism, severe or moderate renal insufficiency, symptomatic heart failure, chronic inflammatory disease); myocardial infarction or stroke within the last six months; statin intolerance; withdrawal of consent; loss to follow-up; poor compliance with treatment.
The number of subjects required for the study was calculated. When considering alpha= 0.05, beta= 0.10, and a magnitude of difference in testosterone levels of 0.59 ng/ml according to Dobs AS et al. study with an estimated common standard deviation of 1.0, the number of subjects required is estimated to be 50.
Protocol and data collection Visit 1: inclusion visit. The subjects were included and signed an informed consent to participate in the study. Visits 1 and 2 were performed on the same day in fasting patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male subjects
- •aged between 40 and 65 years
- •Type 2 diabetes
- •naive to statin
- •patients in whom a high intensity statin therapy was indicated according to the recommendations of the American Diabetes Association 2021 i.e in secondary cardio-vascular prevention or in primary prevention if the patient was aged more than 50 years or if other atherosclerotic cardiovascular disease risk factors were associated.
排除标准
- •the use within the last six months of drugs interfering with steroidogenesis (androgens, anti-androgens, Gn-RH analogues, corticosteroids, antiepileptics, barbiturates or other enzyme inducer or inhibitor)
- •history of endocrinopathy (hypogonadism, testicular tumor, pituitary insufficiency, adrenal insufficiency, uncontrolled hypothyroidism)
- •history of severe systemic disease (hepatic insufficiency, cirrhosis, alcoholism, severe or moderate renal insufficiency, symptomatic heart failure, chronic inflammatory disease)
- •myocardial infarction or stroke within the last six months
- •statin intolerance
- •withdrawal of consent
- •loss to follow-up
- •poor compliance with treatment.
研究组 & 干预措施
type 2 diabetic patients at high cardio vascular risk
atorvastatin 40 mg a day for six months
干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)
结局指标
主要结局
change in testosterone level after atorvastatin treatment
时间窗: six months
decrease in testosterone level
次要结局
- change in DHEAS levels after atorvastatin treatment(six months)
- change in cortisol level after atorvastatin treatment(six months)
研究者
Melika Chihaoui
Professor
University Tunis El Manar