Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l
研究概览
简要总结
Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life.
详细描述
Studies have shown that approximately 50 % of older obese males, who are being treated for diabetes mellitus type 2, also exhibit low testosterone levels. Hypogonadism negatively affects glycemic control, exacerbates early cardio-vascular disease, causes osteoporosis, erectile disfunction, reduces lean body mass, accelerates the accumulation of visceral fat and leads to obesity.
Patients with diabetes mellitus type 2 and confirmed hypogonadism were enrolled into this randomized, double-blind, placebo-controlled clinical study. Placebo group patients were receiving placebo throughout the first year of this study and Testosterone group patients were receiving testosterone undecanoate during first year. Both groups were receiving testosterone undecanoate throughout the second year of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men aged > 35 years
- •body mass index > 30 kg/m2
- •confirmed hypogonadism
- •type 2 diabetes mellitus treated with non-insulin therapy
排除标准
- •previously treated hypogonadism
- •the 2 diabetes mellitus treated with insulin therapy
- •a history of current prostate or breast cancer
- •severe benign prostatic hyperplasia
- •elevated prostate-specific antigen (PSA > 4.0 lg/l)
- •severe heart failure
- •acute coronary event or procedure during the six months leading up to the study
- •chronic obstructive lung disease
- •hypothyroidism
- •severe obstructive sleep apnea (OSA)
- •active infection
- •rheumatoid arthritis
研究组 & 干预措施
Testosterone
Testosterone arm patients were receiving testosterone undecanoate 1000 mg intramuscular injections two years; according to the protocol every 10 weeks
干预措施: Testosterone Undecanoate (Drug)
Placebo
Placebo arm patients were receiving placebo throughout the first year of this study and testosterone undecanoate 1000 mg intramuscular injections during second year.
干预措施: Testosterone Undecanoate (Drug)
Placebo
Placebo arm patients were receiving placebo throughout the first year of this study and testosterone undecanoate 1000 mg intramuscular injections during second year.
干预措施: Placebo (Drug)
结局指标
主要结局
Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l
时间窗: FPG was measured at baseline, after 12 months and after 24 months
The primary outcome measure was change in glycemic control - fasting plasma glucose (FPG) mmol/l
Effects of testosterone replacement therapy on glycemic control - glycated hemoglobin A1c (HbA1c) %
时间窗: HbA1c was measured at baseline, after 12 months and after 24 months
The primary outcome measure was change in glycemic control - glycated hemoglobin A1c (HbA1c) %
Effects of testosterone replacement therapy on parameters of metabolic syndrome - change in HOMA-IR
时间窗: HOMA-IR was calculated at the baseline, after 12 months and after 24 months of clinical trial.
The primary outcome measure was change in Homeostasis model assessment of insulin resistance (HOMA-IR)
Effects of testosterone replacement therapy on vascular function - change in flow mediated dilatation (FMD) %
时间窗: FMD was measured at baseline, after 12 months and after 24 months
The primary outcome measure was change in flow mediated dilatation (FMD) % assessed by vascular ultrasound
Effects of testosterone replacement therapy on vascular morphology - intima-media thickness (IMT)
时间窗: IMT was measured at baseline, after 12 months and after 24 months
The primary outcome measure was change in intima-media thickness (IMT) mm assessed by vascular ultrasound
次要结局
- Effects of testosterone replacement therapy on non-alcoholic fatty liver disease (NAFLD)(Grade of NAFLD was determined at baseline and after 24 months)
- Effects of testosterone replacement therapy on bone mineral density (BMD)(Change in bone mineral density was measured at baseline and after 24 months)
- Effects of testosterone replacement on total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations(Changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations were measured baseline, after 12 months and 24 months)
- Effects of testosterone replacement on prostate specific antigen (PSA)(Prostate specific antigen (PSA) was measured at baseline,3,6,12,15,18 and 24 months)
- Effects of testosterone replacement on hematocrit(Hematocrit was measured at baseline,3,6,12,15,18 and 24 months)
研究者
Kristina Groti
Principal Investigator; MD, PhD, specialist in Internal medicine
University Medical Centre Ljubljana