The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in normal sperm forms from baseline and between the treatment arms
研究概览
简要总结
The goal of this study is to learn whether semaglutide (treatment for type 2 diabetes and obesity) can improve signs and symptoms of hypogonadism in men with type 2 diabetes, obesity and hypogonadism (a condition when levels of testosterone are decreased).
The main questions the study aims to answer are:
- Does semaglutide improve the quality of sperm?
- Does semaglutide improve symptoms of hypogonadism as well as testosterone replacement?
The researchers will compare semaglutide to testosterone replacement to see which drug better treats symptoms of hypogonadism.
- The participants will receive testosterone replacement therapy (intramuscular injection every 10-12 weeks) or magnitude (subcutaneous injection once a week).
- The treatment will last 24 weeks.
- The participants will visit the clinic at the start and the end of the study.
At the visit, the researchers will measure body weight and take a few blood samples. The participants will also be asked to complete several questionnaires and collect a sperm sample.
The participants are free to terminate their participation in the study at any time without giving a reason.
详细描述
Men aged 18 - 65 years with type 2 diabetes on oral antidiabetic treatment, body mass index above 30 kg/m2 and functional hypogonadism (total testosterone below 11 nmol/L and at least 2 symptoms of hypogonadism) are eligible to participate in the study. The participants are randomized to either testosterone undecanoate (100 mg intramuscular injection once per 10-12 weeks) or semaglutide (subcutaneous injection once weekly titrated to 1 mg in concordance with Summary of product characteristics (SmPC) for 24 weeks.
At the beginning of the study and after 24 weeks of treatment the researchers measured anthropometric (body weight, body composition), endocrine (total testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), sex hormone binding globulin (SHBG)) and metabolic parameters (HbA1c, 75-g oral glucose tolerance test (OGTT), insulin, c-peptide). The participants also gave sperm samples and completed self-reported hypogonadism symptom evaluation (Ageing male symptoms (AMS) score, International Index of erectile function 15 (IIEF-15)).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Semaglutide Treatment
干预措施: Semaglutide (Drug)
Testosterone Replacement Therapy
干预措施: Testosterone Undecanoate (Drug)
结局指标
主要结局
Change in normal sperm forms from baseline and between the treatment arms
时间窗: Baseline and 24 weeks
The normal sperm forms will be assessed as total number of sperm with normal morphology and reported as number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
Change in total number of sperm from baseline and between the treatment arms
时间窗: Baseline and 24 weeks
The total number of sperm will be measured and reported in number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
Change in semen volume from baseline and between the treatment arms
时间窗: Baseline and 24 weeks
The semen volume will be measured and reported in mililiters (mL). The higher the value the better the outcome.
Change in sperm concentration from baseline and between the treatment arms
时间窗: Baseline and 24 weeks
The sperm concentration will be measured and reported in number times 10\^6 per mililiter (10\^6/mL). The higher the value the better the outcome.
Change in total motility of sperm from baseline and between the treatment arms
时间窗: Baseline and 24 weeks
The total motility will be assessed as total number of motile sperm and reported as number times 10\^6 per ejaculate (10\^6/ejaculate). The higher the value the better the outcome.
次要结局
- Change in HbA1c from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in fasting serum total cholesterol from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in fasting triglycerides from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in follicle-stimulating hormone (FSH) from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in International index of erectile function 15 (IIEF-15) score from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in Aging male symptoms (AMS) score from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in luteinizing hormone (LH) from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in fasting serum high-density lipoproteins (HDL) cholesterol from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in estimated visceral adipose tissue from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in percentage of body fat from baseline and between the treatment arms(Baseline and 24 weeks)
- Change in fasting serum low-density lipoproteins (LDL) cholesterol from baseline and between the treatment arms(Baseline and 24 weeks)
研究者
Andrej Janez
Professor, PhD, MD
University Medical Centre Ljubljana